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510(k) K842955

SICKLE-HEME A/S HETEROZYGOUS CONTROL by Michclone Associates, Inc. — Product Code GHM

K842955 is an FDA 510(k) premarket notification submitted by Michclone Associates, Inc. for the device "SICKLE-HEME A/S HETEROZYGOUS CONTROL". The FDA issued a decision of Substantially Equivalent on August 9, 1984. The device falls under product code GHM (Test, Sickle Cell), a Class II device regulated under 21 CFR 864.7825. Michclone Associates, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1984
Date Received
July 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 Michclone Associates, Inc.

  • K871676 — ENZYMATIC CHOLESTEROL REAGENT SET (May 18, 1987)
  • K860812 — SICKLE CELL REAGENT SET (April 11, 1986)

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