FDA Product Code JIX: Calibrator, Multi-analyte Mixture

Cleared Dec 27, 1999

K-ASSAY MULTI-ANALYTE CALIBRATOR

K993853

Kamiya Biomedical Co.

Chemistry · 45d

Cleared Nov 26, 1999

K-ASSAY APO A1/B CALIBRATOR SET

K993606

Kamiya Biomedical Co.

Chemistry · 32d

Cleared Oct 18, 1999

HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT

K992845

Elan Holdings, Inc.

Chemistry · 55d

Cleared Oct 08, 1999

HDL-C/LDL-C CALIBRATOR, MODEL 1913-003

K993098

Data Medical Associates, Inc.

Chemistry · 22d

Cleared Aug 19, 1999

OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2

K992086

Olympus America, Inc.

Toxicology · 59d

Cleared Jun 10, 1999

K-ASSAY MICROALBUMIN CALIBRATOR SET

K991166

Kamiya Biomedical Co.

Chemistry · 64d

Cleared Jun 01, 1999

MODIFICATION OF N PROTEIN STANDARD SL

K991181

Dade Behring, Inc.

Chemistry · 55d

Cleared Mar 22, 1999

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

K990460

Roche Diagnostics Corp.

Chemistry · 38d

Cleared Jan 20, 1999

MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR

K984425

Boehringer Mannheim Corp.

Chemistry · 40d

Cleared Dec 23, 1998

SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2

K984014

Beckman Coulter, Inc.

Chemistry · 42d

Cleared Nov 25, 1998

PRECISET SERUM PROTEINS CALIBRATOR

K983469

Boehringer Mannheim Corp.

Chemistry · 55d

Cleared Sep 21, 1998

RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR

K982767

Raichem

Chemistry · 46d

Cleared Sep 01, 1998

ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44

K982501

Alko Diagnostic Corp.

Chemistry · 43d

Cleared Jul 09, 1998

AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2

K981706

Abbott Laboratories

Chemistry · 56d

Cleared Jun 12, 1998

CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO

K981795

Thermo Bioanalysis Corp.

Chemistry · 22d

Cleared May 07, 1998

OLYMPUS SERUM PROTEIN MULTICALIBRATOR

K981305

Olympus America, Inc.

Chemistry · 27d

Cleared Apr 24, 1998

DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109

K981436

Casco Standards

Chemistry · 10d

Cleared Jan 30, 1998

BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS

K974825

Boehringer Mannheim Corp.

Chemistry · 37d

Cleared Dec 19, 1997

MICROPROTEIN STANDARD KIT

K974290

Verichem Laboratories, Inc.

Chemistry · 35d

Cleared Dec 15, 1997

BECKMAN CALIBRATOR 2 (CAL2)

K973932

Beckman Instruments, Inc.

Chemistry · 61d

Cleared Dec 01, 1997

BECKMAN URINE PROTEIN CALIBRATOR (UCAL)

K973928

Beckman Instruments, Inc.

Chemistry · 47d

Cleared Oct 29, 1997

MATRIX PLUS MULTI-CALIBRATOR KIT

K973345

Verichem Laboratories, Inc.

Chemistry · 54d

Cleared Jul 23, 1997

AMMONIA/IRON STANDARD KIT

K972333

Verichem Laboratories, Inc.

Chemistry · 30d

Cleared Jun 03, 1997

SYNCHRON SYSTEMS CAL 5 PLUS

K971283

Beckman Instruments, Inc.

Immunology · 57d