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510(k) K941346

PLASMINOGEN RID TEST KIT by The Binding Site, Ltd. — Product Code DDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1994
Date Received
March 21, 1994
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

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Other clearances for product code DDX

  • 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)
  • 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)