IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)— 510(k) K982078

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K982078 for IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS), Substantially Equivalent on 1998-12-11. Applicant: Diagnostic Products Corp.. Device class: 2.

Clearance details

Applicant
Diagnostic Products Corp.
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
Los Angeles, CA, US
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