510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974695Substantially Equivalent

Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl)

Roche Diagnostic Systems, Inc., Branchburg NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974695 is the FDA 510(k) clearance record for COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL), a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code CKB (Acid Phosphatase, Naphthyl Phosphate). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K974695.

Clearance record

Decision date
Received
(156 days to decision)
Product code
CKB Acid Phosphatase, Naphthyl Phosphate
Regulation
21 CFR 862.1020
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostic Systems, Inc. 1080 Us Hwy. 202, Branchburg NJ
510(k) summary
Summary
Third party review
No

Clearances, product code CKB

Trailing 12 months

FDA records hold no clearances under product code CKB in the trailing twelve months.

FDA records show no clearances under product code CKB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CKB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260