510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K051376Substantially Equivalent

Accuchek Instant Plus Dual Testing System, Accuchek Instant Plus Cholesterol, Accuchek Instant Plus Glucocose

Roche Diagnostics GmbH, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051376 is the FDA 510(k) clearance record for ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE, a class I device, cleared for Roche Diagnostics on under FDA product code CHH (Enzymatic Esterase--Oxidase, Cholesterol). FDA records list 465 510(k) clearances for Roche Diagnostics, from to . As of , FDA records show no recalls naming K051376.

Clearance record

Decision date
Received
(89 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 Diagnostics 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CHH

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