The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Cobas Integra Reagent Cassette For Rheumatoid Factor Ii.
| Device ID | K000534 |
| 510k Number | K000534 |
| Device Name: | COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Kay A Taylor |
| Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-17 |
| Decision Date | 2000-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121498 | K000534 | 000 |