Home / 510(k) Clearances / K860812

510(k) K860812

SICKLE CELL REAGENT SET by Michclone Associates, Inc. — Product Code GHM

K860812 is an FDA 510(k) premarket notification submitted by Michclone Associates, Inc. for the device "SICKLE CELL REAGENT SET". The FDA issued a decision of Substantially Equivalent on April 11, 1986. 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
April 11, 1986
Date Received
March 4, 1986
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)
  • K842955 — SICKLE-HEME A/S HETEROZYGOUS CONTROL (August 9, 1984)

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)
  • 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