The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Integra Reagent Cassette For Apolipoprotein A-1.
| Device ID | K990594 |
| 510k Number | K990594 |
| Device Name: | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 |
| Classification | Alpha-1-lipoprotein, Antigen, Antiserum, Control |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Priscilla A Hamill |
| Correspondent | Priscilla A Hamill ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | DER |
| CFR Regulation Number | 866.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-24 |
| Decision Date | 1999-04-14 |
| Summary: | summary |