CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI)— 510(k) K861080

Name: FDA 510(k) clearance K861080
Creator: U.S. Food and Drug Administration
Published: 1986-04-07

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K861080 for CELLEMATICS VIRAL/CHLAMYDAL TRANSPORT PACK(MODIFI), Substantially Equivalent on 1986-04-07. Applicant: Difco Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 1986-03-21
Decision date: 1986-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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