FDA Product Code GHM: Test, Sickle Cell

Cleared Dec 30, 2002

SICKLE-CHEX SOLUBILITY KIT

K023656

Streck Laboratories, Inc.

Hematology · 61d

Cleared Nov 06, 2001

SICKLE-CHEX

K013316

Streck Laboratories, Inc.

Hematology · 33d

Cleared Jul 01, 1996

SAS SICKLE CELL TEST

K960947

Sa Scientific, Inc.

Hematology · 115d

Cleared Oct 09, 1991

HEMOCARD HEMOGLOBIN S

K911981

Isolab, Inc.

Hematology · 159d

Cleared Apr 15, 1991

HEMOCARD-AS

K910430

Isolab, Inc.

Hematology · 73d

Cleared Jul 31, 1987

THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT

K872217

Pacific Hemostasis

Hematology · 52d

Cleared Apr 11, 1986

SICKLE CELL REAGENT SET

K860812

Michclone Associates, Inc.

Hematology · 38d

Cleared Feb 24, 1986

SICKLE CELL REAGENT SET

K860420

Sterling Diagnostics, Inc.

Hematology · 20d

Cleared Oct 31, 1985

THROMBO SCREEN SICKLE CELL ASSAY SET

K854079

Pacific Hemostasis

Hematology · 24d

Cleared Sep 09, 1984

SICKLING HEMOGLOBIN CONTROLS, NORMAL

K842152

Isolab, Inc.

Hematology · 102d

Cleared Aug 09, 1984

SICKLE-HEME A/S HETEROZYGOUS CONTROL

K842955

Michclone Associates, Inc.

Hematology · 13d

Cleared Jul 20, 1984

SICKLE CELL REAGENT SET

K842368

Livonia Diagnostics, Inc.

Hematology · 35d

Cleared Apr 13, 1984

SICKLE-STAT HEMOGLOBIN S SCREEN KIT

K841272

Clinical Technology Corp.

Hematology · 17d

Cleared Apr 04, 1984

SICKLE HB ASSAY

K841170

Isolab, Inc.

Hematology · 16d

Cleared Jul 28, 1983

SICKLE-HEME A/S CONTROLS & A/A CONTROL

K831871

Anco Medical Reagents & Assoc.

Chemistry · 45d

Cleared Apr 14, 1982

SICKLE-CHECK

K820642

Panmed, Inc.

Hematology · 37d

Cleared Aug 12, 1981

SICKLE CELL REAGENT SET

K811828

Anco Medical Reagents & Assoc.

Chemistry · 44d

Cleared Nov 05, 1979

MONOJECT SICKLE CELL KIT

K791971

Sherwood Medical Co.

Immunology · 34d