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510(k) K841376

WELLCOGEN S. PNEUMONIAE by Wellcome Diagnostics — Product Code GWC

K841376 is an FDA 510(k) premarket notification submitted by Wellcome Diagnostics for the device "WELLCOGEN S. PNEUMONIAE". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code GWC (Antisera, All Types, Streptococcus Pneumoniae), a Class I device regulated under 21 CFR 866.3740. Wellcome Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
April 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, Streptococcus Pneumoniae
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

Other clearances by Wellcome Diagnostics

  • K915203 — D-DIMER WELLCOTEST (HA10) (January 31, 1992)
  • K910797 — STREPTEX ACID EXTRACTION KIT (March 29, 1991)
  • K895461 — WELLCOLEX COLOUR SHIGELLA TEST ZC51 (January 11, 1990)
  • K890146 — WELLCOLEX COLOUR SALMONELLA TEST ZL 50 (February 16, 1989)
  • K875311 — WELLCOZYME HSV WZO2 (August 3, 1988)
  • K861628 — WELLCOZYME ROTAVIRUS WZ01 (January 21, 1987)
  • K864206 — REVEAL COLOUR STREP A ZL16 (January 13, 1987)
  • K861634 — THE WELLCOME ROTAVIRUS LATEX TEST ZL40 (October 29, 1986)
  • K854852 — WELLCOGEN BACTERIAL ANTIGEN KIT (February 4, 1986)
  • K854851 — WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24 (February 4, 1986)

Other clearances for product code GWC

  • K884965 — BACTIGEN(R) MENINGITIDIS PANEL (February 7, 1989)
  • K884966 — BACTIGEN(R) S. PNEUMONIAE (February 7, 1989)
  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K862848 — LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (December 18, 1986)
  • K842239 — VENTRESCREEN STREP A TEST (July 2, 1984)
  • K831887 — BACTIGEN S. PNEUMONIAE (September 26, 1983)
  • K821960 — BBL PNEUMOSLIDE TEST (July 30, 1982)
  • K802337 — PHADEBACT PNEUMOCOCCUS TEST (October 31, 1980)

FDA data resources