MID-LEVEL IGG KIT CAT. NO. 9315— 510(k) K891299

Name: FDA 510(k) clearance K891299
Creator: U.S. Food and Drug Administration
Published: 1989-03-22

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K891299 for MID-LEVEL IGG KIT CAT. NO. 9315, Substantially Equivalent on 1989-03-22. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code DAQ
Device class: Class 1
Regulation: 21 CFR 866.5540
Advisory panel: Immunology
Date received: 1989-03-13
Decision date: 1989-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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