The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobras Integra Acid Prostatic Phosphatase (acpp) Cobad Integra Benzodiazepines With B-glucuronidase (bnzgl).
| Device ID | K974695 |
| 510k Number | K974695 |
| Device Name: | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) |
| Classification | Acid Phosphatase, Naphthyl Phosphate |
| 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 | CKB |
| CFR Regulation Number | 862.1020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-16 |
| Decision Date | 1998-05-21 |
| Summary: | summary |