MODIFICATION OF SEROCARD RUBELLA IGG TEST— 510(k) K902571

Substantially Equivalent

Disease Detection International, Inc.

FDA 510(k) clearance K902571 for MODIFICATION OF SEROCARD RUBELLA IGG TEST, Substantially Equivalent on 1990-09-05. Applicant: Disease Detection International, Inc.. Device class: 2.

Clearance details

Applicant
Disease Detection International, Inc.
Product code
Code LFX
Device class
Class 2
Regulation
21 CFR 866.3510
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
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