ROTA-STAT— 510(k) K864811

Substantially Equivalent

Intl. Diagnostic Laboratories, Ltd.

FDA 510(k) clearance K864811 for ROTA-STAT, Substantially Equivalent on 1987-08-25. Applicant: Intl. Diagnostic Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Intl. Diagnostic Laboratories, Ltd.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1986-12-09
Decision date: 1987-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Israel, IL

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Recent devices under product code LIQ

K990842 — SAS ROTA TEST1999-08-09
K972895 — VIDAS ROTAVIRUS (RTV) ASSAY1997-10-03
K971585 — IMMUNOCARD STAT! ROTAVIRUS1997-08-20
K964424 — ROTAVIRUS EIA1997-08-08
K965092 — VIDAS ROTAVIRUS ASSAY1997-05-05

More clearances from Intl. Diagnostic Laboratories, Ltd.

K864228 — APO B., IMMUNOTURBIDIMETRIC ASSAY1987-03-12
K864393 — APOLIPOPROTEIN A1 (APO A1) IMMUNOTURBIDIMETRIC1987-01-16
K843367 — ROTAVIRUS ENZYME IMMUNOASSAY1985-06-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.