510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800493Substantially Equivalent

Bactogen-H. Influenzae Type B

Armkel, LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800493 is the FDA 510(k) clearance record for BACTOGEN-H. INFLUENZAE TYPE B, a class II device, cleared for Armkel, LLC on under FDA product code GRO (Antisera, Fluorescent, All Types, Hemophilus Spp.). FDA records list 68 510(k) clearances for Armkel, LLC, from to . As of , FDA records show no recalls naming K800493.

Clearance record

Decision date
Received
(31 days to decision)
Product code
GRO Antisera, Fluorescent, All Types, Hemophilus Spp.
Regulation
21 CFR 866.3300
Device class
Class II
Review panel
Microbiology
Applicant
Armkel, LLC 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GRO

Trailing 12 months

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

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