CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000— 510(k) K860292

Name: FDA 510(k) clearance K860292
Creator: U.S. Food and Drug Administration
Published: 1986-02-05

Substantially Equivalent

Difco Laboratories, Inc.

FDA 510(k) clearance K860292 for CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000, Substantially Equivalent on 1986-02-05. Applicant: Difco Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Difco Laboratories, Inc.
Product code: Code KIR
Device class: Class 1
Regulation: 21 CFR 864.2280
Advisory panel: Hematology
Date received: 1986-01-28
Decision date: 1986-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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