510(k) K974695
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) by
Roche Diagnostic Systems, Inc.
— Product Code CKB
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 1998
- Date Received
- December 16, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid Phosphatase, Naphthyl Phosphate
- Device Class
- Class II
- Regulation Number
- 862.1020
- Review Panel
- CH
- Submission Type