AS LATEX PLUS— 510(k) K842256

Substantially Equivalent

Biokit USA, Inc.

FDA 510(k) clearance K842256 for AS LATEX PLUS, Substantially Equivalent on 1984-06-19. Applicant: Biokit USA, Inc.. Device class: 1.

Clearance details

Applicant: Biokit USA, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1984-06-07
Decision date: 1984-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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