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510(k) K854572

COATEST PLASMINOGEN by Kabivitrum, Inc. — Product Code DDX

K854572 is an FDA 510(k) premarket notification submitted by Kabivitrum, Inc. for the device "COATEST PLASMINOGEN". The FDA issued a decision of Substantially Equivalent on February 26, 1986. The device falls under product code DDX (Plasminogen, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5715. Kabivitrum, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1986
Date Received
November 14, 1985
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 Kabivitrum, Inc.

  • K884058 — COATEST PROTEIN C (December 13, 1988)
  • K844664 — THE I.V. BAG (May 6, 1985)
  • K833891 — COATEST HEPARIN (January 30, 1984)
  • K833890 — COATEST ANTIPLASMIN (January 30, 1984)
  • K833892 — COATEST FACTOR VIII (January 30, 1984)
  • K832114 — COATEST FACTOR X (August 26, 1983)
  • K812829 — COATEST ANTITHROMBIN (December 30, 1981)

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)
  • K850410 — GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY (May 8, 1985)
  • K832591 — DIACROM *PLG (November 21, 1983)
  • 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