ClearanceBrief
Panels › Clinical Chemistry › Product code JIT · Class 2

Calibrator, Secondary

Regulation 862.1150

0510(k)s in 12 months (245 all time)
1recalls in 12 months (55 all time)
40recalls that name a 510(k)
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Top companies in JIT

Decided510(k)Device and applicantCode
Aug 15, 1996K962594ACA PLUS FT4 CALIBRATOR
Dade Intl., Inc.
JIT
Jul 23, 1996K954326STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY
Solarcare Technologies Corp,Inc.
JIT
Aug 31, 1995K952815DUPONT LIPASE CALIBRATOR
Dupont Medical Products
JIT
Nov 2, 1994K944516FLUIDS PACK
Alko Diagnostic Corp.
JIT
Sep 14, 1994K943704LIPASE CALIBRATOR
The DU Pont Co.
JIT
Mar 11, 1994K934843URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Nov 8, 1991K913371TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL
Creative Laboratory Products, Inc.
JIT
Mar 29, 1991K910962CHOLESTEROL CALIBRATOR SET
Casco Standards
JIT
Feb 27, 1991K910160ELECTROPHORESIS CONTROL
Seradyn, Inc.
JIT
Nov 28, 1990K904698SECONDARY CALIBRATORS
Bionostics, Inc.
JIT
Jan 18, 1990K895649COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN.
Ventrex Laboratories, Inc.
JIT
Jan 18, 1990K895648COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
Ventrex Laboratories, Inc.
JIT
Oct 31, 1989K892329OSMOMETER STANDARD SOLUTIONS
D.R.G. Scientific Industries
JIT
Aug 15, 1989K891999CHLORIDE STANDARDS ITEM #SR1041
Em Diagnostic Systems, Inc.
JIT
Jul 20, 1989K893139DOCUMENT(TM) URIC ACID LINEARITY TEST SET
Casco Standards
JIT
Dec 14, 1988K884197DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET
Casco Standards
JIT
Oct 25, 1988K882059BILIRUBIN STANDARD
Verichem Laboratories, Inc.
JIT
Oct 6, 1988K883306BINAS LUTEINIZING HORMONE IRMA TEST KIT
Binax, Inc.
JIT
Jul 21, 1988K882259DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023
Diagnostic Chemicals, Ltd. (Usa), CA
JIT
Dec 14, 1987K873743PARAMAX ISE CHLORIDE CALIBRATOR
Baxter Healthcare Corp
JIT
Sep 29, 1987K871759G-GT STANDARD CALIBRATOR
Wako Chemicals USA, Inc.
JIT
Sep 11, 1987K872073BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052
American Monitor Corp.
JIT
Aug 21, 1987K872451BILE ACIDS CALIBRATOR
Sigma Diagnostics, Inc.
JIT
Jul 22, 1987K872263TOTAL BILIRUBIN STANDARD CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 27, 1987K871756CREATININE STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871768URIC ACID STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871767UREA N STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871766TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871765PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871764INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871763NEFA STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871762MAGNESIUM STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871758GLUCOSE STANDARD SOLUTION CALIBRATOR
Wako Chemicals USA, Inc.
JIT
May 26, 1987K871150ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8
Beckman Instruments, Inc.
JIT
Mar 19, 1987K870673ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Aug 19, 1986K862525EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
Em Diagnostic Systems, Inc.
JIT
Jul 1, 1986K861314CHOLESTEROL CALIBRATORS
Sigma Diagnostics, Inc.
JIT
Dec 19, 1985K854784ABSORBANCE (ABS) TEST PAK
Diagnostic Systems
JIT
Sep 30, 1985K853887LIQUI-SERA CHEM. MULTIPLE CALIBRATORS
Biodiagnostic Intl
JIT
Sep 16, 1985K853533ABSORBANCE TEST SOLUTION
Diagnostic Systems
JIT
Jul 12, 1985K852461CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET
Medical Analysis Systems, Inc.
JIT
May 31, 1985K852067DIRECT BILIRUBEN CALIBRATIONS
Data Medical Associates, Inc.
JIT
May 10, 1985K851670CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/
Medical Analysis Systems, Inc.
JIT
Dec 11, 1984K844468TRIGLYCERIDE CALIBRATOR
Sigma Diagnostics, Inc.
JIT
Nov 9, 1984K844047FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
Fisher Diagnostics
JIT
Sep 13, 1984K843112ROCHE STANDARDS FOR URIC ACID
Roche Diagnostic Systems, Inc.
JIT
Aug 17, 1984K842099ACTH STANDARD MATRIX
Diagnostic Systems Laboratories, Inc.
JIT
Apr 13, 1984K840772ALCOHOL & AMMONIA CALIBRATOR II
American Dade
JIT
Apr 13, 1984K840771ALCOHOL & AMMONIA CALIBRATOR I
American Dade
JIT
Apr 4, 1984K840775CARBON DIOXIDE CALIBRATOR II
American Dade
JIT

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