The following data is part of a premarket notification filed by Microprobe Corp. with the FDA for Affirm Processor.
| Device ID | K923268 |
| 510k Number | K923268 |
| Device Name: | AFFIRM PROCESSOR |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | MICROPROBE CORP. 7390 LINCOLN WAY Garden Grove, CA 92641 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns MICROPROBE CORP. 7390 LINCOLN WAY Garden Grove, CA 92641 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1992-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902501077 | K923268 | 000 |
| 00382902501008 | K923268 | 000 |
| 00382902119180 | K923268 | 000 |