DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST— 510(k) K892202

Name: FDA 510(k) clearance K892202
Creator: U.S. Food and Drug Administration
Published: 1989-09-13

Substantially Equivalent

Gull Laboratories, Inc.

FDA 510(k) clearance K892202 for DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST, Substantially Equivalent on 1989-09-13. Applicant: Gull Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Gull Laboratories, Inc.
Product code: Code LFX
Device class: Class 2
Regulation: 21 CFR 866.3510
Advisory panel: Microbiology
Date received: 1989-04-03
Decision date: 1989-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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