510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002011Substantially Equivalent

Glutartest 1 Reagent Strip

Integrated Biomedical Technology, Inc., Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002011 is the FDA 510(k) clearance record for GLUTARTEST 1 REAGENT STRIP, a class II device, cleared for Integrated Biomedical Technology, Inc. on under FDA product code MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant). FDA records list 3 510(k) clearances for Integrated Biomedical Technology, Inc., from to . As of , FDA records show no recalls naming K002011.

Clearance record

Decision date
Received
(203 days to decision)
Product code
MSY Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Regulation
21 CFR 876.5665
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Integrated Biomedical Technology, Inc. 2931 Moose Trl., Elkhart IN
510(k) summary
Statement
Third party review
No

Clearances, product code MSY

Trailing 12 months

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

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