The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Serum Protein Multicalibrator.
| Device ID | K981305 |
| 510k Number | K981305 |
| Device Name: | OLYMPUS SERUM PROTEIN MULTICALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| 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 | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-10 |
| Decision Date | 1998-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590080761 | K981305 | 000 |