TOXOGEN— 510(k) K981263

Substantially Equivalent

Instrumentation Laboratory CO

FDA 510(k) clearance K981263 for TOXOGEN, Substantially Equivalent on 1998-08-06. Applicant: Instrumentation Laboratory CO. Device class: 2.

Clearance details

Applicant: Instrumentation Laboratory CO
Product code: Code GMM
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1998-04-07
Decision date: 1998-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GMM

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K830870 — POLYCHACO INDIRECT HEMAGGLUTINATION1983-08-12
K802452 — TOXOTEST-MT EIKEN KIT1980-12-18

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Data sourced from openFDA. This site is unofficial and independent of the FDA.