The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Hemoglobin A1c Control N And Control P.
| Device ID | K972721 |
| 510k Number | K972721 |
| Device Name: | ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Contact | James W Haynes |
| Correspondent | James W Haynes ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg, NJ 08876 -3771 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1997-08-06 |