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510(k) K832591

DIACROM *PLG by Wellcome Diagnostics — Product Code DDX

K832591 is an FDA 510(k) premarket notification submitted by Wellcome Diagnostics for the device "DIACROM *PLG". The FDA issued a decision of Substantially Equivalent on November 21, 1983. The device falls under product code DDX (Plasminogen, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5715. Wellcome Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1983
Date Received
August 2, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasminogen, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5715
Review Panel
HE
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 DDX

  • K941346 — PLASMINOGEN RID TEST KIT (September 9, 1994)
  • K884766 — BERICHROM(R) PLASMINOGEN (January 4, 1989)
  • K864212 — IL TEST 97573-15, PLASMINOGEN ASSAY (December 4, 1986)
  • K854572 — COATEST PLASMINOGEN (February 26, 1986)
  • K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (May 8, 1985)
  • K812625 — ACA PLASMINOGEN TEST PACK (September 29, 1981)
  • K811777 — HELENA PLASMINOGEN QUIPLATE PROCEDURE (July 2, 1981)
  • K781478 — PLASMINOGEN ASSAY (November 15, 1978)
  • K772085 — LAS-R HUMAN PLASMINOGEN TEST (January 24, 1978)

FDA data resources