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510(k) K841170

SICKLE HB ASSAY by Isolab, Inc. — Product Code GHM

K841170 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "SICKLE HB ASSAY". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code GHM (Test, Sickle Cell), a Class II device regulated under 21 CFR 864.7825. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
March 19, 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 Isolab, Inc.

  • K951014 — ISOLAB'S T4 TEST KIT (October 18, 1996)
  • K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (February 1, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)
  • K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (September 21, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)
  • K944185 — ISOSCAN (November 17, 1994)
  • K934013 — RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (April 26, 1994)
  • K923153 — HEMOCARD, HEMOGLOBIN C ASSAY (January 27, 1994)

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