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 |