510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831133Substantially Equivalent

Amebiasis Bio-Enzabead Screen Kit

Bionetic Laboratory Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831133 is the FDA 510(k) clearance record for AMEBIASIS BIO-ENZABEAD SCREEN KIT, a class II device, cleared for Bionetic Laboratory Products on under FDA product code KHW (Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.). FDA records list 8 510(k) clearances for Bionetic Laboratory Products, from to . As of , FDA records show no recalls naming K831133.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Regulation
21 CFR 866.3220
Device class
Class II
Review panel
Microbiology
Applicant
Bionetic Laboratory Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KHW

Trailing 12 months

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

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