SPQ TEST SYSTEM FOR COMPLEMENT C4— 510(k) K850585

Name: FDA 510(k) clearance K850585
Creator: U.S. Food and Drug Administration
Published: 1985-03-01

Substantially Equivalent

Applications Lab

FDA 510(k) clearance K850585 for SPQ TEST SYSTEM FOR COMPLEMENT C4, Substantially Equivalent on 1985-03-01. Applicant: Applications Lab. Device class: 2.

Clearance details

Applicant: Applications Lab
Product code: Code DBI
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 1985-02-13
Decision date: 1985-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE2000-03-01

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K850586 — SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M1985-03-14
K850587 — SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN1985-03-14
K850584 — SPQ TEST SYSTEM FOR HAPTOGLOBIN1985-03-05
K850588 — SPQ TEST SYSTEM FOR COMPLEMENT C31985-03-05
K850589 — SPQ TEST SYSTEM FOR TRANSFERRIN1985-03-05

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