HILLCREST AMEBIASIS IHA TEST— 510(k) K853448

Name: FDA 510(k) clearance K853448
Creator: U.S. Food and Drug Administration
Published: 1985-08-28

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K853448 for HILLCREST AMEBIASIS IHA TEST, Substantially Equivalent on 1985-08-28. Applicant: Hillcrest Biologicals. Device class: 2.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1985-08-16
Decision date: 1985-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHW

view all

K170728 — E. HISTOLYTICA QUIK CHEK2017-06-07
K994101 — E. HISTOLYTICA II1999-12-21
K955895 — E. HISTOLYTICA TEST1996-08-30
K954996 — TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM1996-08-08
K944791 — ENTAMOEBA TEST1995-03-09

More clearances from Hillcrest Biologicals

view all

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.