Pathology · PMA · 1995
AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
BD DIAGNOSTICS. Approved by FDA on 29 September 1995 under submission P950009, product code NMN (instrument, clip, forming/cutting, reprocessed). What FDA's record says, in FDA's words.
Device record · P950009
- Device. AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEMDEVICE
- Company. BD DIAGNOSTICSCOMPANY
- Decision. 29 September 1995, PMA, apprDECISION
- Panel. PathologyPANEL
- Product code. NMN, Instrument, Clip, Forming/Cutting, ReprocessedCODE
- Regulation. 21 CFR 882.4190, Class IREG
- Source. FDA database entrySOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA approved it for
The Indications for Use statement could not be read from a public decision document for this submission on the retrieval date (the document is absent, scanned without text, or filed under another number). FDA's database entry is the place to read it.
The product code's definition, from FDA's classification record. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code NMN. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code NMN, in Pathology, or approved in 1995. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.