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 |