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510(k) K960947

SAS SICKLE CELL TEST by Sa Scientific, Inc. — Product Code GHM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1996
Date Received
March 8, 1996
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

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  • K100227 — SAS FLUALERT A&B, SAS INFLUENZA A TEST (February 23, 2010)
  • K080380 — SAS INFLUENZA A & B TEST (July 23, 2009)
  • K061496 — SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST (June 28, 2007)
  • K041441 — SAS INFLUENZA A TEST (July 22, 2004)
  • K041439 — SAS INFLUENZA B TEST (July 22, 2004)
  • K030628 — SAS RSV CONTROL KIT (March 17, 2003)
  • K022845 — SAS RSV TEST (January 29, 2003)
  • K022683 — SAS BLOOD/SERUM/URINE/URINE HCG (December 16, 2002)
  • K023270 — SAS STREPALERT (October 17, 2002)

Other clearances for product code GHM

  • K023656 — SICKLE-CHEX SOLUBILITY KIT (December 30, 2002)
  • K013316 — SICKLE-CHEX (November 6, 2001)
  • K911981 — HEMOCARD HEMOGLOBIN S (October 9, 1991)
  • K910430 — HEMOCARD-AS (April 15, 1991)
  • K872217 — THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT (July 31, 1987)
  • 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)