SHIGELLA SERA-CHEK— 510(k) K813191

Substantially Equivalent

Lab Ability, Inc.

FDA 510(k) clearance K813191 for SHIGELLA SERA-CHEK, Substantially Equivalent on 1981-12-03. Applicant: Lab Ability, Inc.. Device class: 2.

Clearance details

Applicant: Lab Ability, Inc.
Product code: Code LIA
Device class: Class 2
Regulation: 21 CFR 866.3660
Advisory panel: Microbiology
Date received: 1981-11-17
Decision date: 1981-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K830133 — Q-CHECK CULTI-LOOPS1983-02-09
K830134 — Q-CHECK REAGENT STANDARDS1983-01-09

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