DETECTADOT TM SYSTEM 2000 CMV IGM TEST— 510(k) K893230

Name: FDA 510(k) clearance K893230
Creator: U.S. Food and Drug Administration
Published: 1989-12-18

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K893230 for DETECTADOT TM SYSTEM 2000 CMV IGM TEST, Substantially Equivalent on 1989-12-18. Applicant: Gull Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1989-04-28
Decision date: 1989-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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