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510(k) K820450

THROMBOSCREEN by Pacific Hemostasis — Product Code GIT

K820450 is an FDA 510(k) premarket notification submitted by Pacific Hemostasis for the device "THROMBOSCREEN". The FDA issued a decision of Substantially Equivalent on March 26, 1982. The device falls under product code GIT (Reagent & Control, Partial Thromboplastin Time), a Class II device regulated under 21 CFR 864.7925. Pacific Hemostasis has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1982
Date Received
February 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Pacific Hemostasis

  • K000679 — THROMBOSTRATE CONTROL PLASMAS (March 24, 2000)
  • K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D (February 18, 2000)
  • K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C (September 3, 1999)
  • K992278 — HEPARIN CONTROL PLASMA LEVEL 1 (August 26, 1999)
  • K992279 — HEPARIN CONTROL PLASMA LEVEL 2 (August 26, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K990046 — PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA (February 17, 1999)
  • K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL) (December 1, 1998)
  • K984130 — COAGULATION CONTROL LEVEL 2 (ABNORMAL) (December 1, 1998)
  • K984131 — COAGULATION CONTROL LEVEL 3 (ABNORMAL) (December 1, 1998)

Other clearances for product code GIT

  • K890051 — BIOTRACK APTT CONTROLS (February 23, 1989)
  • K881999 — PLATELIN(R) EXCEL L (August 17, 1988)
  • K880711 — CLP 0.02 M CALCIUM CHLORIDE SOLUTION. (March 18, 1988)

FDA data resources