ECHO TYPE 9 CF ANTIGEN— 510(k) K844967

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K844967 for ECHO TYPE 9 CF ANTIGEN, Substantially Equivalent on 1985-03-05. Applicant: Hillcrest Biologicals. Device class: 1.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GNL
Device class: Class 1
Regulation: 21 CFR 866.3205
Advisory panel: Microbiology
Date received: 1984-12-24
Decision date: 1985-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Long Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GNL

K844695 — ECHO TYPE 4 CF ANTIGEN1985-03-05

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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.