BACTI-SWAB DRY— 510(k) K013711

Substantially Equivalent

Remel Co.

FDA 510(k) clearance K013711 for BACTI-SWAB DRY, Substantially Equivalent on 2001-11-26. Applicant: Remel Co.. Device class: 1.

Clearance details

Applicant
Remel Co.
Product code
Code LIO
Device class
Class 1
Regulation
21 CFR 866.2900
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lenexa, KS, US
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