The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Au600 Clinical Chemistry Analyzer.
| Device ID | K961274 |
| 510k Number | K961274 |
| Device Name: | OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-02 |
| Decision Date | 1996-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987666543009 | K961274 | 000 |
| 14987666542996 | K961274 | 000 |
| 14987666542989 | K961274 | 000 |