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

Company510(k)sRecalls
Dade Behring, Inc.290
Siemens Healthcare Diagnostics1117
Roche Diagnostics180
Abbott Laboratories610
Wako Chemicals USA, Inc.151
Beckman Coulter, Inc.84
Ortho Clinical Diagnostics48
E.I. Dupont DE Nemours & Co., Inc.100
Diamond Diagnostics, Inc.90
Tosoh Bioscience, Inc.53
Decided510(k)Device and applicantCode
Apr 4, 1984K840774CARBON DIOXIDE CALIBRATOR I
American Dade
JIT
Mar 23, 1984K840218TRIGLYCERIDE AQUEOUS STANDARDS
Preventive Diagnostics Corp.
JIT
Jan 4, 1984K833702ACA THYROXINE UPTAKE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Dec 27, 1983K833700ACA THYROXINE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Aug 11, 1983K832094BILIRUBIN CALIBRATORS & CONTROL
Gilford Diagnostics
JIT
Mar 24, 1983K830469BILIRUBIN STANDARD-LYOPHILIZED
Dow Instruments & Reagents, Inc.
JIT
Nov 16, 1982K823025KM - KAL 2
Kmn Products, Inc.
JIT
Nov 16, 1982K823024KM - KAL 1
Kmn Products, Inc.
JIT
Nov 16, 1982K823023KM-KAL L6
Kmn Products, Inc.
JIT
Nov 16, 1982K823022KM-KAL 6
Kmn Products, Inc.
JIT
Nov 16, 1982K823021KM - KAL 5
Kmn Products, Inc.
JIT
Nov 16, 1982K823020KM-KAL 4
Kmn Products, Inc.
JIT
Nov 16, 1982K823019KM-KAL 3
Kmn Products, Inc.
JIT
Oct 27, 1982K822852TRIGLYCERIDE CALIBRATOR
Harleco Diagnostics
JIT
Sep 21, 1982K822496SERA CHEM SMAC CALIBRATORS
Fisher Scientific Co., LLC
JIT
Sep 14, 1982K822479BILIRUBIN CALIBRATOR #65071
Emd Chemicals, Inc.
JIT
Sep 14, 1982K822478ALBUMIN STANDARD, #65070
Emd Chemicals, Inc.
JIT
Sep 14, 1982K822475TOTAL PROTEIN STANDARD, #65074
Emd Chemicals, Inc.
JIT
Sep 2, 1982K822334BILIRUBIN CALIBRATORS
Gilford Diagnostics
JIT
Dec 11, 1980K802823CHOLESTEROL STANDARDS
Mallinckrodt Critical Care
JIT
Apr 21, 1980K800770SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT
Sclavo, Inc.
JIT
Feb 26, 1980K800220CALIBRATOR NO. 1 & 2, & WASH SOLUTION
Fisher Scientific Co., LLC
JIT
Dec 6, 1979K792290TSH STANDARDS & DILUENT
Amersham Corp.
JIT
Aug 16, 1979K791312CATALOG #4-2520 CHLORIDOMETER CHLORIDE
Buchler Instruments, Inc.
JIT
Aug 31, 1978K781423DUAL COMPONENT STANDARDS
Abbott Laboratories
JIT
Aug 14, 1978K781071STANDARDS, HORMONE, THYROID STIMULATING
Pcl-Ria, Inc.
JIT
Aug 14, 1978K781069T3 STANDARDS IN HUMAN SERUM
Pcl-Ria, Inc.
JIT
Aug 10, 1978K781072TRAP-BLOOD VESSEL STABILIZATION DEVICE
Ayer, Patrick, M.D.
JIT
Jun 22, 1978K780447URIC ACID REFERENCE SERA
Macomb Chemical Co.
JIT
Apr 5, 1978K780295CALIBRATORS, CARBON DIOXIDE
E.I. Dupont DE Nemours & Co., Inc.
JIT
Feb 28, 1978K772153FLAME PHOTOMETER STANDARD
Alko Scientific Co.
JIT
Dec 6, 1977K772106PH CALIBRATION BUFFERS
General Diagnostics
JIT
Oct 25, 1977K771804ACA AMMONIA CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Oct 25, 1977K771803ACA PHOSPHORUS CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Oct 25, 1977K771802ACA IRON CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Oct 25, 1977K771801ACA CARBON DIOXIDE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Oct 25, 1977K771797ACA TRIGLYCERIDE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIT
Jul 21, 1977K771216CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET
Union Carbide Corp.
JIT
Jul 21, 1977K771215CENTRIFICHEM TRIGLYCERIDE CALI. STD.
Union Carbide Corp.
JIT
Jul 11, 1977K771143INORGANIC PHOSPHORUS STANDARDS
Worthington Biochemical Corp.
JIT
Mar 1, 1977K770277CHOLESTEROL STANDARDS
Worthington Biochemical Corp.
JIT
Jan 31, 1977K770127CENTRIFICHEM 200MG/DL CHOL. CAL. STD.
Union Carbide Corp.
JIT
Jan 31, 1977K770126CENTRIFICHEM CHOLES. CALIB. STD. SET
Union Carbide Corp.
JIT
Dec 21, 1976K761197CHOLESTEROL CALIBRATOR
Beckman Instruments, Inc.
JIT
Oct 5, 1976K760349BILIRUBIN REF., SIGMA STOCK NO. 605-10
Sigma Chemical Co.
JIT

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