LYME DISEASE IFA (IGM)— 510(k) K883767

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K883767 for LYME DISEASE IFA (IGM), Substantially Equivalent on 1989-03-15. Applicant: Hillcrest Biologicals. Device class: 2.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1988-09-06
Decision date: 1989-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Hillcrest Biologicals

K913617 — ARBOVIRUS IGG IFA TEST1992-12-03
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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.