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510(k) K872217

THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT by Pacific Hemostasis — Product Code GHM

K872217 is an FDA 510(k) premarket notification submitted by Pacific Hemostasis for the device "THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT". The FDA issued a decision of Substantially Equivalent on July 31, 1987. The device falls under product code GHM (Test, Sickle Cell), a Class II device regulated under 21 CFR 864.7825. Pacific Hemostasis has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1987
Date Received
June 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Sickle Cell
Device Class
Class II
Regulation Number
864.7825
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 GHM

  • K023656 — SICKLE-CHEX SOLUBILITY KIT (December 30, 2002)
  • K013316 — SICKLE-CHEX (November 6, 2001)
  • K960947 — SAS SICKLE CELL TEST (July 1, 1996)
  • K911981 — HEMOCARD HEMOGLOBIN S (October 9, 1991)
  • K910430 — HEMOCARD-AS (April 15, 1991)
  • K860812 — SICKLE CELL REAGENT SET (April 11, 1986)
  • K860420 — SICKLE CELL REAGENT SET (February 24, 1986)
  • K854079 — THROMBO SCREEN SICKLE CELL ASSAY SET (October 31, 1985)
  • K842152 — SICKLING HEMOGLOBIN CONTROLS, NORMAL (September 9, 1984)
  • K842955 — SICKLE-HEME A/S HETEROZYGOUS CONTROL (August 9, 1984)

FDA data resources