The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Apolipoprotein A1 Immunoturbidimetric Reagent.
| Device ID | K952425 |
| 510k Number | K952425 |
| Device Name: | OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT |
| Classification | Turbidimetric Method, Lipoproteins |
| 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 | JHN |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-24 |
| Decision Date | 1995-07-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590080778 | K952425 | 000 |
| 15099590010393 | K952425 | 000 |