510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855236Substantially Equivalent

Diagnostic Reagent Tst-Rpla

Oxoid U.S.A., Inc., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855236 is the FDA 510(k) clearance record for DIAGNOSTIC REAGENT TST-RPLA, a class I device, cleared for Oxoid U.S.A., Inc. on under FDA product code GTN (Antisera, Fluorescent, All Types, Staphylococcus Spp.). FDA records list 93 510(k) clearances for Oxoid U.S.A., Inc., from to . As of , FDA records show no recalls naming K855236.

Clearance record

Decision date
Received
(308 days to decision)
Product code
GTN Antisera, Fluorescent, All Types, Staphylococcus Spp.
Regulation
21 CFR 866.3700
Device class
Class I
Review panel
Microbiology
Applicant
Oxoid U.S.A., Inc. 9017 Red Branch Rd., Columbia MD
Third party review
No

Clearances, product code GTN

Trailing 12 months

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

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