SPQ(TM) ANTIBODY REAGENT SET II FOR IGM— 510(k) K890561

Name: FDA 510(k) clearance K890561
Creator: U.S. Food and Drug Administration
Published: 1989-02-23

Substantially Equivalent

Atlantic Antibodies

FDA 510(k) clearance K890561 for SPQ(TM) ANTIBODY REAGENT SET II FOR IGM, Substantially Equivalent on 1989-02-23. Applicant: Atlantic Antibodies. Device class: 2.

Clearance details

Applicant: Atlantic Antibodies
Product code: Code CFQ
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1989-01-24
Decision date: 1989-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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K951013 — OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT1995-04-17

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K892526 — SPQ TM TEST SYSTEM II FOR CRP1989-05-09
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K890563 — SPQ(TM) ANTIBODY REAGENT SET II FOR TRF1989-03-03
K890416 — SPQ(TM) ANTIBODY REAGENT SET II FOR IGG1989-02-22
K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT1989-02-22

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