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510(k) K833890

COATEST ANTIPLASMIN by Kabivitrum, Inc. — Product Code LGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
November 9, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Alpha-2-Antiplasmin
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Kabivitrum, Inc.

  • K884058 — COATEST PROTEIN C (December 13, 1988)
  • K854572 — COATEST PLASMINOGEN (February 26, 1986)
  • K844664 — THE I.V. BAG (May 6, 1985)
  • K833892 — COATEST FACTOR VIII (January 30, 1984)
  • K833891 — COATEST HEPARIN (January 30, 1984)
  • K832114 — COATEST FACTOR X (August 26, 1983)
  • K812829 — COATEST ANTITHROMBIN (December 30, 1981)

Other clearances for product code LGP

  • K864213 — IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY (November 25, 1986)
  • K850411 — GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY (May 8, 1985)
  • K803110 — PROTEOLYTIC ENZYME CONTROL (February 17, 1981)
  • K802840 — ALPHA-ANTIPLASM ASSAY (February 17, 1981)