510(k) K974695
K974695 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)". The FDA issued a decision of Substantially Equivalent on May 21, 1998. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
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