FDA Product Code KRZ: Calibrator For Hemoglobin And Hematocrit Measurement

Cleared Aug 26, 2005

C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C

K052101

Roche Diagnostics

Chemistry · 23d

Cleared Jun 10, 2004

CDS HEMATOLOGY CALIBRATOR (CDS CAL)

K041130

Clinical Diagnostic Solutions, Inc.

Hematology · 41d

Cleared Dec 18, 1996

THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS

K962864

Alko Diagnostic Corp.

Hematology · 148d

Cleared Jul 24, 1995

ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS

K951071

Alko Diagnostic Corp.

Hematology · 138d

Cleared Sep 10, 1990

CELL-DYN CALIBRATOR

K902892

Unipath , Ltd.

Hematology · 70d

Cleared Jan 25, 1990

RAICHEM TM HEMOGLOBIN CALIBRATOR

K896921

Reagents Applications, Inc.

Hematology · 45d

Cleared Aug 15, 1989

HGB-CAL SET/MULTIPLE

K893984

R&D Systems, Inc.

Hematology · 71d

Cleared Nov 22, 1988

MSI-CAL 7

K883703

Medical Specialties, Inc.

Hematology · 84d

Cleared Nov 22, 1988

MSI-CAL 16

K883850

Medical Specialties, Inc.

Hematology · 84d

Cleared Nov 22, 1988

MSI-CAL 8

K883851

Medical Specialties, Inc.

Hematology · 84d

Cleared Apr 15, 1987

CYANMETHEMOGLOBIN STANDARD

K871283

U. S. Diagnostics, Inc.

Hematology · 15d

Cleared Dec 17, 1984

QCA HEMOGLOBIN KIT

K843695

Bd Becton Dickinson Vacutainer Systems Preanalytic

Hematology · 89d

Cleared Apr 19, 1984

DADE HEMATOLOGY CALIBRATOR PLUS

K840010

American Dade

Hematology · 106d

Cleared Feb 21, 1984

CAL-CHEX, A HEMATOLOGY CALIBRATOR

K840261

Streck Laboratories, Inc.

Hematology · 47d

Cleared Jul 18, 1983

CALIBRATOR 282

K831872

Bionostics, Inc.

Hematology · 35d

Cleared Jul 30, 1982

SERALYZER HEMOGLOBIN CALIBRATORS

K822046

Miles Laboratories, Inc.

Hematology · 18d

Cleared May 02, 1980

HEMESPEC CHECK SET

K800852

Helena Laboratories

Hematology · 17d

Cleared Dec 31, 1979

SANDARE CYANMETHEMOGLOBIN STANDARD

K792358

Sandare Chemical Co., Inc.

Hematology · 40d