The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Crp T Control N.
| Device ID | K982087 |
| 510k Number | K982087 |
| Device Name: | ROCHE CRP T CONTROL N |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Contact | Rita Smith |
| Correspondent | Rita Smith ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville, NJ 08876 -3771 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-15 |
| Decision Date | 1998-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630915316 | K982087 | 000 |