510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951595Substantially Equivalent

Roche Cobas Integra Analyzer, Reagent Cassettes

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

K951595 is the FDA 510(k) clearance record for ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, a class II device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code CGX (Alkaline Picrate, Colorimetry, Creatinine). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show 7 recalls naming K951595.

Clearance record

Decision date
Received
(155 days to decision)
Product code
CGX Alkaline Picrate, Colorimetry, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Roche Diagnostic Systems, Inc. Branchburg Township, Somerville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code CGX

Trailing 12 months
2 clearances under product code CGX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260