510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943008Substantially Equivalent

Bioscan Reagent Strips

Genesis Labs, Inc., Edina MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943008 is the FDA 510(k) clearance record for BIOSCAN REAGENT STRIPS, a class I device, cleared for Genesis Labs, Inc. on under FDA product code JJB (Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)). FDA records list 3 510(k) clearances for Genesis Labs, Inc., from to . As of , FDA records show no recalls naming K943008.

Clearance record

Decision date
Received
(45 days to decision)
Product code
JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
Regulation
21 CFR 862.1115
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Genesis Labs, Inc. 5182 W. 76th St., Edina MN
510(k) summary
Summary
Third party review
No

Clearances, product code JJB

Trailing 12 months

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

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