510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973284Substantially Equivalent

Cobas Integra Hdl-Cholesterol Direct

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

K973284 is the FDA 510(k) clearance record for COBAS INTEGRA HDL-CHOLESTEROL DIRECT, a class I device, cleared for Roche Diagnostic Systems, Inc. on under FDA product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). FDA records list 296 510(k) clearances for Roche Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K973284.

Clearance record

Decision date
Received
(107 days to decision)
Product code
CHH Enzymatic Esterase--Oxidase, Cholesterol
Regulation
21 CFR 862.1175
Device class
Class I
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 CHH

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