The following data is part of a premarket notification filed by Olympus America Inc. with the FDA for Olympus Iga Reagent.
| Device ID | K073489 |
| 510k Number | K073489 |
| Device Name: | OLYMPUS IGA REAGENT |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | OLYMPUS AMERICA INC. LISMEEHAN, O, CALLAGHAN'S MILLS Co. Clare, IE |
| Contact | Stephanie G Donnelly |
| Correspondent | Stephanie G Donnelly OLYMPUS AMERICA INC. LISMEEHAN, O, CALLAGHAN'S MILLS Co. Clare, IE |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-12 |
| Decision Date | 2008-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590011574 | K073489 | 000 |