BACTI-SWAB— 510(k) K910180

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K910180 for BACTI-SWAB, Substantially Equivalent on 1991-05-10. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant: Remel Co.
Product code: Code JSM
Device class: Class 1
Regulation: 21 CFR 866.2390
Advisory panel: Microbiology
Date received: 1991-01-15
Decision date: 1991-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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