510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982089Substantially Equivalent

Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test Strips

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

K982089 is the FDA 510(k) clearance record for ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS, a class II device, cleared for Boehringer Mannheim Corp. on under FDA product code LFR (Glucose Dehydrogenase, Glucose). FDA records list 340 510(k) clearances for Boehringer Mannheim Corp., from to . As of , FDA records show 7 recalls naming K982089.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LFR Glucose Dehydrogenase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Boehringer Mannheim Corp. 9115 Hague Rd., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code LFR

Trailing 12 months

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

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