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510(k) K873382

PLATELET EXTRACT REAGENT by Bio/Data Corp. — Product Code GGW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1987
Date Received
August 24, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Time, Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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  • K853897 — CITREX H (October 10, 1985)
  • K853246 — CALCIUM CHLORIDE (August 13, 1985)
  • K852484 — PLASTINEX (August 12, 1985)

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  • K033471 — PHOSPHOLIN ES AND CALCIUM CHLORIDE (February 4, 2004)
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  • K963111 — COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S (December 23, 1996)
  • K945940 — COATEST(R) APC(TM) RESISTANCE (August 7, 1995)
  • K941210 — PTT-LT TEST KIT (March 21, 1995)