PERMACLEAR SOLUTION CAT. NO. 4950— 510(k) K861490

Name: FDA 510(k) clearance K861490
Creator: U.S. Food and Drug Administration
Published: 1986-05-06

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K861490 for PERMACLEAR SOLUTION CAT. NO. 4950, Substantially Equivalent on 1986-05-06. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code KEM
Device class: Class 1
Regulation: 21 CFR 864.4010
Advisory panel: Pathology
Date received: 1986-04-22
Decision date: 1986-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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