ALA SWAB— 510(k) K801493

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K801493 for ALA SWAB, Substantially Equivalent on 1980-08-13. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1980-06-26
Decision date: 1980-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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