QUANTA LITE RUBEOLA (MEASLES) IGG— 510(k) K971620

Name: FDA 510(k) clearance K971620
Creator: U.S. Food and Drug Administration
Published: 1997-07-22

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K971620 for QUANTA LITE RUBEOLA (MEASLES) IGG, Substantially Equivalent on 1997-07-22. Applicant: Inova Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LJB
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 1997-05-01
Decision date: 1997-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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K904083 — RUBEOLA IGM ELISA TEST1991-01-03

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