510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850639Substantially Equivalent

Enzymatic Alpha-Amylase Reagent Kit

Bio-Analytics Laboratories, Inc., Palm City FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850639 is the FDA 510(k) clearance record for ENZYMATIC ALPHA-AMYLASE REAGENT KIT, a class II device, cleared for Bio-Analytics Laboratories, Inc. on under FDA product code CIW (Starch-Dye Bound Polymer, Amylase). FDA records list 19 510(k) clearances for Bio-Analytics Laboratories, Inc., from to . As of , FDA records show no recalls naming K850639.

Clearance record

Decision date
Received
(14 days to decision)
Product code
CIW Starch-Dye Bound Polymer, Amylase
Regulation
21 CFR 862.1070
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bio-Analytics Laboratories, Inc. One Bio-Analytics Pl., Palm City FL
Third party review
No

Clearances, product code CIW

Trailing 12 months

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

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