DIAGNOSTIC KITS & KIT COMPONENTS— 510(k) K812434

Name: FDA 510(k) clearance K812434
Creator: U.S. Food and Drug Administration
Published: 1981-09-23

Substantially Equivalent

Diagnostica, Inc.

FDA 510(k) clearance K812434 for DIAGNOSTIC KITS & KIT COMPONENTS, Substantially Equivalent on 1981-09-23. Applicant: Diagnostica, Inc.. Device class: 1.

Clearance details

Applicant: Diagnostica, Inc.
Product code: Code LHT
Device class: Class 1
Regulation: 21 CFR 866.3700
Advisory panel: Microbiology
Date received: 1981-08-25
Decision date: 1981-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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