ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP— 510(k) K001547

Substantially Equivalent

Ab Biodisk

FDA 510(k) clearance K001547 for ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP, Substantially Equivalent on 2000-08-07. Applicant: Ab Biodisk.

Clearance details

Applicant: Ab Biodisk
Product code: Code JWY
Advisory panel: Microbiology
Date received: 2000-05-18
Decision date: 2000-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Solna, SE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.