ECHO TYPE 16 CF ANTIGEN— 510(k) K853156

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K853156 for ECHO TYPE 16 CF ANTIGEN, Substantially Equivalent on 1985-11-07. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GNK
Device class: Class 1
Regulation: 21 CFR 866.3205
Advisory panel: Microbiology
Date received: 1985-07-30
Decision date: 1985-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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Recent devices under product code GNK

K853157 — ECHO TYPE 11 CF ANTIGEN1985-11-07
K853165 — ECHO TYPE 30 CF ANTIGEN1985-11-07

More clearances from Hillcrest Biologicals

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K913906 — Q FEVER IGG IFA TEST1992-10-21
K922374 — Q FEVER IGM IFA TEST1992-10-21
K900206 — LYME DISEASE IGM ELISA1991-06-28

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