Cleared Traditional

COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)

K974695 · Roche Diagnostic Systems, Inc. · Chemistry

May 1998

Decision

156d

Days

Class 2

Risk

About This 510(k) Submission

K974695 is an FDA 510(k) clearance for the COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL), a Acid Phosphatase, Naphthyl Phosphate (Class II — Special Controls, product code CKB), submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on May 21, 1998, 156 days after receiving the submission on December 16, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number	K974695 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 1997
Decision Date	May 21, 1998
Days to Decision	156 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF