LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965— 510(k) K992252

Name: FDA 510(k) clearance K992252
Creator: U.S. Food and Drug Administration
Published: 1999-08-10

Substantially Equivalent

Chemicon Intl., Inc.

FDA 510(k) clearance K992252 for LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965, Substantially Equivalent on 1999-08-10. Applicant: Chemicon Intl., Inc.. Device class: 2.

Clearance details

Applicant: Chemicon Intl., Inc.
Product code: Code LYF
Device class: Class 2
Regulation: 21 CFR 866.3780
Advisory panel: Microbiology
Date received: 1999-07-06
Decision date: 1999-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Temecula, CA, US

Download summary PDF View on FDA.gov ↗

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