WELLCOGEN S. PNEUMONIAE— 510(k) K841376

Substantially Equivalent

Wellcome Diagnostics

FDA 510(k) clearance K841376 for WELLCOGEN S. PNEUMONIAE, Substantially Equivalent on 1984-05-02. Applicant: Wellcome Diagnostics. Device class: 1.

Clearance details

Applicant: Wellcome Diagnostics
Product code: Code GWC
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1984-04-03
Decision date: 1984-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Recent devices under product code GWC

K884965 — BACTIGEN(R) MENINGITIDIS PANEL1989-02-07
K884966 — BACTIGEN(R) S. PNEUMONIAE1989-02-07
K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE1987-03-25
K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-1101986-12-18
K842239 — VENTRESCREEN STREP A TEST1984-07-02

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.