510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802423Substantially Equivalent

Phadebact Haemophilus Test

Pharmacia, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802423 is the FDA 510(k) clearance record for PHADEBACT HAEMOPHILUS TEST, a class II device, cleared for Pharmacia, Inc. on under FDA product code GRO (Antisera, Fluorescent, All Types, Hemophilus Spp.). FDA records list 129 510(k) clearances for Pharmacia, Inc., from to . As of , FDA records show no recalls naming K802423.

Clearance record

Decision date
Received
(40 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
Pharmacia, Inc. 4221 Richmond Rd., NW, Walker MI
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