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510(k) K895461

WELLCOLEX COLOUR SHIGELLA TEST ZC51 by Wellcome Diagnostics — Product Code GNB

K895461 is an FDA 510(k) premarket notification submitted by Wellcome Diagnostics for the device "WELLCOLEX COLOUR SHIGELLA TEST ZC51". The FDA issued a decision of Substantially Equivalent on January 11, 1990. The device falls under product code GNB (Antisera, All Types, Shigella Spp.), a Class II device regulated under 21 CFR 866.3660. Wellcome Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1990
Date Received
September 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, Shigella Spp.
Device Class
Class II
Regulation Number
866.3660
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)
  • 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)
  • K851691 — WILLCOGEN MENINGITIDIS KIT ZL25 (June 10, 1985)

Other clearances for product code GNB

  • K961537 — SAS SHIGELLA SONNEI FORM II ANTISERUM (May 31, 1996)
  • K961533 — SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM (May 20, 1996)
  • K961551 — SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM (May 20, 1996)
  • K961556 — SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM (May 20, 1996)
  • K961540 — SAS SHIGELLA SONNEI GROUP D ANTISERUM (May 20, 1996)
  • K961534 — SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) (May 20, 1996)
  • K961553 — SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM (May 20, 1996)
  • K961546 — SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM (May 20, 1996)
  • K961547 — SAS SHIGELLA BOYDII TYPE 14 ANTISERUM (May 20, 1996)
  • K961539 — SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM (May 20, 1996)

FDA data resources