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510(k) K841272

SICKLE-STAT HEMOGLOBIN S SCREEN KIT by Clinical Technology Corp. — Product Code GHM

K841272 is an FDA 510(k) premarket notification submitted by Clinical Technology Corp. for the device "SICKLE-STAT HEMOGLOBIN S SCREEN KIT". The FDA issued a decision of Substantially Equivalent on April 13, 1984. The device falls under product code GHM (Test, Sickle Cell), a Class II device regulated under 21 CFR 864.7825. Clinical Technology Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1984
Date Received
March 27, 1984
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 Clinical Technology Corp.

  • K925080 — TEK-LUBE (January 31, 1994)
  • K872867 — BIOSIGN (July 6, 1988)
  • K880166 — BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 (February 18, 1988)
  • K872705 — BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT) (September 1, 1987)
  • K855138 — BOVIE ULTRASONIC SURGICAL SYSTEM (November 10, 1986)
  • K854231 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE/ACCES (May 2, 1986)
  • K853507 — STERI-GRIP (September 5, 1985)
  • K852986 — GLYCO-SEP/ALC TEST KIT FOR SEPARAT OF HEMOGLOBIN (August 19, 1985)
  • K844565 — BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT) (February 21, 1985)
  • K823077 — URINARY BLADDER TEMP. SENSOR #81-003 (March 9, 1983)

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)
  • 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)

FDA data resources