BIOSCAN E12— 510(k) K781421

Substantially Equivalent

Clinifax Industries, Ltd.

FDA 510(k) clearance K781421 for BIOSCAN E12, Substantially Equivalent on 1978-09-20. Applicant: Clinifax Industries, Ltd.. Device class: 1.

Clearance details

Applicant: Clinifax Industries, Ltd.
Product code: Code JJS
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1978-08-17
Decision date: 1978-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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