The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Au400 Clinical Chemistry Analyzer.
| Device ID | K981743 |
| 510k Number | K981743 |
| Device Name: | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| 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 | CKB |
| Subsequent Product Code | CDO |
| Subsequent Product Code | CDQ |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CFQ |
| Subsequent Product Code | CFR |
| Subsequent Product Code | CGS |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CHH |
| Subsequent Product Code | CHJ |
| Subsequent Product Code | CIC |
| Subsequent Product Code | CIG |
| Subsequent Product Code | CIT |
| Subsequent Product Code | CIX |
| Subsequent Product Code | CJE |
| Subsequent Product Code | CZW |
| Subsequent Product Code | DCN |
| Subsequent Product Code | DEF |
| Subsequent Product Code | DGI |
| Subsequent Product Code | DHR |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-18 |
| Decision Date | 1998-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987666542972 | K981743 | 000 |
| 14987666542965 | K981743 | 000 |