LEPTOSPIROSIS IHA— 510(k) K880417

Substantially Equivalent

Hillcrest Biologicals

FDA 510(k) clearance K880417 for LEPTOSPIROSIS IHA, Substantially Equivalent on 1988-04-12. Applicant: Hillcrest Biologicals. Device class: 2.

Clearance details

Applicant: Hillcrest Biologicals
Product code: Code GRY
Device class: Class 2
Regulation: 21 CFR 866.3350
Advisory panel: Microbiology
Date received: 1988-02-01
Decision date: 1988-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cypress, CA, US

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Recent devices under product code GRY

K002024 — PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA2000-11-22

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.