510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012286Substantially Equivalent

Modification To:cobas Integra Hdl-Cholesterol Plus 2Nd Generation

Roche Diagnostics GmbH, Indianapolis IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K012286 is the FDA 510(k) clearance record for MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION, a class I device, cleared for Roche Diagnostics Corp. on under FDA product code LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl). FDA records list 465 510(k) clearances for Roche Diagnostics Corp., from to . As of , FDA records show 2 recalls naming K012286.

Clearance record

Decision date
Received
(19 days to decision)
Product code
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Roche Diagnostics Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code LBS

Trailing 12 months

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

FDA records show no clearances under product code LBS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LBS, 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