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510(k) K890146

WELLCOLEX COLOUR SALMONELLA TEST ZL 50 by Wellcome Diagnostics — Product Code GRM

K890146 is an FDA 510(k) premarket notification submitted by Wellcome Diagnostics for the device "WELLCOLEX COLOUR SALMONELLA TEST ZL 50". The FDA issued a decision of Substantially Equivalent on February 16, 1989. The device falls under product code GRM (Antisera, All Groups, Salmonella Spp.), a Class II device regulated under 21 CFR 866.3550. Wellcome Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1989
Date Received
January 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, Salmonella Spp.
Device Class
Class II
Regulation Number
866.3550
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)
  • 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)
  • K851691 — WILLCOGEN MENINGITIDIS KIT ZL25 (June 10, 1985)

Other clearances for product code GRM

  • K961951 — SAS SALMONELLA O FACTOR 6 ANTISERUM (June 18, 1996)
  • K961958 — SAS SALMONELLA H Z4 COMPLEX ANTISERUM (June 18, 1996)
  • K961956 — SAS SALMONELLA H G,M,Q ANTISERMU (June 18, 1996)
  • K961961 — SAS SALMONELLA H F,G,T ANTISERUM (June 18, 1996)
  • K961953 — SAS SALMONELA H Z24 ANTISERUM (June 18, 1996)
  • K961954 — SAS SALMONELLA H Z35 ANTISERUM (June 18, 1996)
  • K961960 — SAS SALMONELLA H Z4, Z24 ANTISERUM (June 18, 1996)
  • K961964 — SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM (June 18, 1996)
  • K961963 — SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM (June 18, 1996)
  • K961949 — SAS SALMONELLA O FACTOR 14 ANTISERUM (June 18, 1996)

FDA data resources