WELLCOZYME ROTAVIRUS WZ01— 510(k) K861628

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K861628 for WELLCOZYME ROTAVIRUS WZ01, Substantially Equivalent on 1987-01-21. Applicant: Wellcome Diagnostics. Device class: 1.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code LIQ
Device class: Class 1
Regulation: 21 CFR 866.3405
Advisory panel: Microbiology
Date received: 1986-04-29
Decision date: 1987-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Pk, NC, US

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Recent devices under product code LIQ

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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 Wellcome Diagnostics

K915203 — D-DIMER WELLCOTEST (HA10)1992-01-31
K910797 — STREPTEX ACID EXTRACTION KIT1991-03-29
K895461 — WELLCOLEX COLOUR SHIGELLA TEST ZC511990-01-11
K890146 — WELLCOLEX COLOUR SALMONELLA TEST ZL 501989-02-16
K875311 — WELLCOZYME HSV WZO21988-08-03

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