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510(k) K851949

STAPHAUREX ZL30 by Wellcome Diagnostics — Product Code GTN

K851949 is an FDA 510(k) premarket notification submitted by Wellcome Diagnostics for the device "STAPHAUREX ZL30". The FDA issued a decision of Substantially Equivalent on May 22, 1985. The device falls under product code GTN (Antisera, Fluorescent, All Types, Staphylococcus Spp.), a Class I device regulated under 21 CFR 866.3700. Wellcome Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1985
Date Received
May 3, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Staphylococcus Spp.
Device Class
Class I
Regulation Number
866.3700
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 GTN

  • K855236 — DIAGNOSTIC REAGENT TST-RPLA (November 4, 1986)
  • K855233 — DIAGNOSTIC REAGENT SET-RPLA (November 4, 1986)
  • K791453 — AGGLUTINOTEST-STAPHYLOLISIN (September 24, 1979)

FDA data resources