ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM— 510(k) K003069

Substantially Equivalent

Quest Intl., Inc.

FDA 510(k) clearance K003069 for ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM, Substantially Equivalent on 2000-11-27. Applicant: Quest Intl., Inc.. Device class: 2.

Clearance details

Applicant
Quest Intl., Inc.
Product code
Code MID
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
North Miami, FL, US
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