510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842393Substantially Equivalent

Boehringer Mannheim Diag. Blood Glucose

Boehringer Mannheim Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842393 is the FDA 510(k) clearance record for BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code CGA (Glucose Oxidase, Glucose). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K842393.

Clearance record

Decision date
Received
(59 days to decision)
Product code
CGA Glucose Oxidase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CGA

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