ROTALEX— 510(k) K860529

Substantially Equivalent

Orion Corp.

FDA 510(k) clearance K860529 for ROTALEX, Substantially Equivalent on 1986-03-04. Applicant: Orion Corp.. Device class: 1.

Clearance details

Applicant: Orion Corp.
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1986-02-11
Decision date: 1986-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 20101 Turku, FI

Download summary PDF View on FDA.gov ↗

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 Orion Corp.

K912391 — RUBALEX, MODIFICATION1992-05-04
K901637 — RESUBMITTED MODIFIED RUBALEX1990-04-26
K884650 — RESUBMITTED SCANORA1989-03-16
K890199 — DENTOCULT SM-STRIP MUTANS1989-03-02
K881505 — MAMEX DC MG111988-06-10

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