510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K896454Substantially Equivalent

Chemstrip(r) 10 with Sg Urine Test Strips

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

K896454 is the FDA 510(k) clearance record for CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show no recalls naming K896454.

Clearance record

Decision date
Received
(63 days to decision)
Product code
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation
21 CFR 862.1340
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
Third party review
No

Clearances, product code JIL

Trailing 12 months

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

FDA records show no clearances under product code JIL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JIL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260