510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981263Substantially Equivalent

Toxogen

Instrumentation Laboratory Co., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981263 is the FDA 510(k) clearance record for TOXOGEN, a class II device, cleared for Instrumentation Laboratory CO on under FDA product code GMM (Antigens, Iha, Toxoplasma Gondii). FDA records list 327 510(k) clearances for Instrumentation Laboratory CO, from to . As of , FDA records show no recalls naming K981263.

Clearance record

Decision date
Received
(121 days to decision)
Product code
GMM Antigens, Iha, Toxoplasma Gondii
Regulation
21 CFR 866.3780
Device class
Class II
Review panel
Microbiology
Applicant
Instrumentation Laboratory CO 180 Hartwell Rd., Bedford MA
510(k) summary
Summary
Third party review
No

Clearances, product code GMM

Trailing 12 months

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

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