SPQ(TM) TEST SYSTEM FOR MICROALBUMIN— 510(k) K884298

Name: FDA 510(k) clearance K884298
Creator: U.S. Food and Drug Administration
Published: 1988-11-02

Substantially Equivalent

Atlantic Antibodies

FDA 510(k) clearance K884298 for SPQ(TM) TEST SYSTEM FOR MICROALBUMIN, Substantially Equivalent on 1988-11-02. Applicant: Atlantic Antibodies. Device class: 1.

Clearance details

Applicant: Atlantic Antibodies
Product code: Code JZJ
Device class: Class 1
Regulation: 21 CFR 866.5060
Advisory panel: Immunology
Date received: 1988-10-12
Decision date: 1988-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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K890561 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGM1989-02-23
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Data sourced from openFDA. This site is unofficial and independent of the FDA.