TWO-STEP ACID FAST BACTERIA STAIN— 510(k) K851494

Name: FDA 510(k) clearance K851494
Creator: U.S. Food and Drug Administration
Published: 1985-04-29

Substantially Equivalent

Accra Laboratories, Inc.

FDA 510(k) clearance K851494 for TWO-STEP ACID FAST BACTERIA STAIN, Substantially Equivalent on 1985-04-29. Applicant: Accra Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Accra Laboratories, Inc.
Product code: Code JTS
Device class: Class 1
Regulation: 21 CFR 864.1850
Advisory panel: Hematology
Date received: 1985-04-15
Decision date: 1985-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, NJ, US

Download summary PDF View on FDA.gov ↗

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K843427 — GILL PAPANICOLAOU STAIN EA-1 & 2 OG-61984-10-02
K843426 — EOSIN Y 1% ALCOHOLIC1984-09-27
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