CMV-IHA— 510(k) K852494

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K852494 for CMV-IHA, Substantially Equivalent on 1985-09-16. Applicant: Hillcrest Biologicals. Device class: 2.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code LJO
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1985-06-12
Decision date: 1985-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJO

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K001767 — DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM2000-08-07
K974901 — HYBRID CAPTURE SYSTEM CMV DNA ASSAY1998-09-29
K974456 — CMVGEN1998-05-01

More clearances from Hillcrest Biologicals

K913617 — ARBOVIRUS IGG IFA TEST1992-12-03
K913618 — ARBOVIRUS IGM IFA TEST1992-12-03
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.