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510(k) K833077

WELLCOGEN H. INFLUENZAL ZL21 by Wellcome Diagnostics — Product Code GRD

K833077 is an FDA 510(k) premarket notification submitted by Wellcome Diagnostics for the device "WELLCOGEN H. INFLUENZAL ZL21". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code GRD (Antiserum, Hai, Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Wellcome Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1984
Date Received
September 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Hai, Mumps Virus
Device Class
Class I
Regulation Number
866.3380
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)

FDA data resources