The following data is part of a premarket notification filed by Biochem Immunosystems (u.s.), Inc. with the FDA for Personallab Automated Microplate Analyzer.
| Device ID | K971761 |
| 510k Number | K971761 |
| Device Name: | PERSONALLAB AUTOMATED MICROPLATE ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | James Safranko |
| Correspondent | James Safranko BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1997-07-22 |
| Summary: | summary |