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Panels › Clinical Chemistry › Product code JIX · Class 2

Calibrator, Multi-Analyte Mixture

Regulation 862.1150

0510(k)s in 12 months (302 all time)
1recalls in 12 months (73 all time)
60recalls that name a 510(k)
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Top companies in JIX

Company510(k)sRecalls
Siemens Healthcare Diagnostics1220
Alko Diagnostic Corp.210
Dade Behring, Inc.180
Roche Diagnostics142
Ortho-Clinical Diagnostics, Inc.411
Randox Laboratories, Ltd.510
Bhp Diagnostix, Inc.110
Roche Diagnostic Systems, Inc.90
Beckman Instruments, Inc.80
Boehringer Mannheim Corp.80
Decided510(k)Device and applicantCode
Mar 10, 1983K830341SALT BRIDGE SOLUTION & URINE DILUENT
Shaban Mfg. Co.
JIX
Dec 9, 1982K823044KM-KAL L3
Kmn Products, Inc.
JIX
Nov 5, 1982K823046KM-KAL L5
Kmn Products, Inc.
JIX
Nov 5, 1982K823045KM-KAL L4
Kmn Products, Inc.
JIX
Nov 5, 1982K823043KM-KAL L2
Kmn Products, Inc.
JIX
Nov 5, 1982K823042KM-KAL L1
Kmn Products, Inc.
JIX
Nov 5, 1982K822937GLUCOSE/UREA NITROGEN STANDARD
Emd Chemicals, Inc.
JIX
Aug 24, 1982K822289CO2/CI STANDARDS
Gilford Diagnostics
JIX
Jul 13, 1982K821885REF. ELECTRODE SOL'N.;STANDARD B
Avl Scientific Corp.
JIX
Jul 2, 1982K821794NOVA V FLUIDS PACK & EXTERNAL STANDARDS
Shaban Mfg. Co.
JIX
Jun 14, 1982K821623NOVA IV FLUIDS PACK & EXTERNAL STANDARDS
Shaban Mfg. Co.
JIX
May 3, 1982K821030NOVA II FLUIDS PACK
Shaban Mfg. Co.
JIX
Apr 26, 1982K820947NOVA III FLUIDS PACK
Shaban Mfg. Co.
JIX
Apr 1, 1982K820701NOVA I FLUIDS PACK
Shaban Mfg. Co.
JIX
Apr 1, 1982K820700EXTERNAL STANDARDS-SODIUMNPOTASSIUM
Shaban Mfg. Co.
JIX
Jan 22, 1982K813127SODIUM & POTASSIUM PRODUCTS
Alko Diagnostic Corp.
JIX
Dec 18, 1981K813411DOCUMENT LINEARITY TEST STANDARDS
North American Standards
JIX
Oct 19, 1981K812649BECKMAN ICS CALIBRATOR
Beckman Instruments, Inc.
JIX
Jul 23, 1981K811921HITACHI 705 CALIBRATOR
Boehringer Mannheim Corp.
JIX
Apr 17, 1981K810964BIO SET TM PHOSPHOROUS CALIBRATOR
Boehringer Mannheim Corp.
JIX
Jan 9, 1981K803051FLAME PHOTOMETRY REAGENTS
Laboratory Products, Inc.
JIX
Dec 11, 1980K802825COMBINED GLUCOSE AND BUN STANDARDS
Mallinckrodt Critical Care
JIX
Dec 11, 1980K802824COMBUNED CALCIUM AND PHOSPHORUS STD.
Mallinckrodt Critical Care
JIX
Dec 11, 1980K802633BUN/GLUCOSE STANDARDS
Gilford Diagnostics
JIX
Dec 11, 1980K802632ALBUMIN/TOTAL PROTEIN STANDARDS
Gilford Diagnostics
JIX
Dec 10, 1980K802741CENTRIFICHEM COMB. SERUM-BASED CALIB.
Union Carbide Corp.
JIX
Jun 26, 1980K801222REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER
Simmler, Inc.
JIX
Apr 29, 1980K800910GAL-PUT CONTROLS, NORMAL&DEFICIENT
Sigma Chemical Co.
JIX
Jan 21, 1980K800043CESIUM DILUENT (1.5 MM/L)
Gilford Diagnostics
JIX
Jan 21, 1980K800041SODIUM/POTASSIUM 140/5 MEQ/L)
Gilford Diagnostics
JIX
Jan 21, 1980K800040SODIUM/POTASSIUM (100/100 MEQ/E)
Gilford Diagnostics
JIX
Dec 31, 1979K792487SERACON-SRII
Bhp Diagnostix, Inc.
JIX
Dec 31, 1979K792486SERACON-SRI (PROD. # D029
Bhp Diagnostix, Inc.
JIX
Dec 31, 1979K792485SERACON-SRI
Bhp Diagnostix, Inc.
JIX
Dec 6, 1979K792384PRINCIPAL ANALYTE REFERENCE SERUM
Beckman Instruments, Inc.
JIX
Nov 13, 1979K792013LANCER L-INA HUMAN REFERENCE SERUM
Sherwood Medical Industries
JIX
Oct 17, 1979K791874CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD
Gilford Diagnostics
JIX
Oct 11, 1979K791956SERACON CAL D025
Bhp Diagnostix, Inc.
JIX
Sep 17, 1979K791694CALIBRATOR II
Hi Chem, Inc.
JIX
Sep 17, 1979K791693CALIBRATOR I
Hi Chem, Inc.
JIX
Feb 26, 1979K782039SERACON-N
Bhp Diagnostix, Inc.
JIX
Feb 8, 1979K782037SERACON-A
Bhp Diagnostix, Inc.
JIX
Dec 4, 1978K781758SERACON-SRII
Bhp Diagnostix, Inc.
JIX
Dec 4, 1978K781757SERACON-SRI
Bhp Diagnostix, Inc.
JIX
Nov 15, 1978K781702CALIBRATOR, BOVINE SERUM
Bio-Reagents & Diagnostics, Inc.
JIX
May 19, 1978K780553COMP. CLIN. CHEM. REF. SERUM-BENCHMARK
Beckman Instruments, Inc.
JIX
Apr 18, 1977K770012Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C
Hyland Therapeutic Div., Travenol Laboratories
JIX
Apr 18, 1977K770011Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B
Hyland Therapeutic Div., Travenol Laboratories
JIX
Apr 18, 1977K770010Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A
Hyland Therapeutic Div., Travenol Laboratories
JIX
Apr 15, 1977K770494BLOOD GAS ANALYZER-CALIBRATION GAS
Gardner Cryogenics
JIX

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