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JIX

302 FDA 510(k) clearances · Product code

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RecordFirmDate
QM300 CALIBRATOR B PACK (K875282)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-17
BIOTROL CALIBRANT LEVEL 2 (K875304)Biotrol, USA, Inc.1988-02-03
BIOTROL CALIBRANT LEVEL 3 (K875318)Biotrol, USA, Inc.1988-02-02
BIOTROL CALIBRANT LEVEL 1 (K875288)Biotrol, USA, Inc.1988-02-02
PARAMAX URINE/CSF CALIBRATOR (K874587)Baxter Healthcare Corp1988-01-05
REAGENT A AND REAGENT B (K874413)Seradyn, Inc.1988-01-05
PROTEIN STANDARD CALIBRATOR (K871755)Wako Chemicals USA, Inc.1987-11-23
MULTI ANALYTE MIXTURES, CALIBRATORS (K873116)Biotrol, USA, Inc.1987-09-02
BIOTROL REFERENCE (K873118)Biotrol, USA, Inc.1987-09-02
PARAMAX URINE/CSF CALIBRATOR (K872789)American Dade1987-09-02
FLAME PHOTOMETER STANDARD #60081 120 NA/2K (K871182)In Vitro Diagnostics, Inc.1987-05-28
FLAME PHOTOMETER STANDARD #60082 140 NA/5K (K871183)In Vitro Diagnostics, Inc.1987-05-28
FLAME PHOTOMETER STANDARD #60083 160 NA/8K (K871184)In Vitro Diagnostics, Inc.1987-05-28
QM300 CALIBRATOR A PACK (K871341)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-21
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 (K871638)Em Diagnostic Systems, Inc.1987-05-12
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR (K871664)Instrumentation Laboratory CO1987-05-08
DU PONT LIQUID MULTI-ANALYTE CALIBRATOR (K864909)E.I. Dupont DE Nemours & Co., Inc.1987-02-13
SOLUTION B- NA 50MEQ/L, K 40 MEQ/L (K863502)Reagent Laboratory, Inc.1986-10-21
PARAMAX ELECTROLYTE CALIBRATOR (K863489)American Dade1986-09-29
ACE II (TRI-LEVEL) (K863095)Medical Analysis Systems, Inc.1986-09-26
SERACON(TM) CAL (PRODUCT NO. DO35) (K862594)Bhp Diagnostix, Inc.1986-08-19
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95 (K862703)Em Diagnostic Systems, Inc.1986-08-04
DU PONT DRUG CALIBRATOR (K861786)E.I. Dupont DE Nemours & Co., Inc.1986-07-29
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II (K860765)Em Diagnostic Systems, Inc.1986-04-07
QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A (K855014)Kallestad Laboratories, Inc.1986-03-14
PARAMAX COMPREHENSIVE CALIBRATOR (K855199)American Dade1986-02-19
DMA CALIBRATORS (K854092)Data Medical Associates, Inc.1985-10-25
INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU (K851990)Alpkem Corp.1985-06-25
CORNING CERTAIN -ISE (K851939)Corning Medical & Scientific1985-06-14
FISHER DIAGNOSTICS KDA CALIBRATOR II (K851151)Fisher Scientific Co., LLC1985-05-20
FISHER DIAGNOSTICS KDA CALIBRATOR I (K851150)Fisher Scientific Co., LLC1985-05-20
COBAS CALIBRATOR SERUM (K850859)Roche Diagnostic Systems, Inc.1985-05-10
CALIBRATOR B 88133 (K850405)Hi Chem, Inc.1985-04-01
ROCHE STANDARDS FOR CHLORIDE & CO2 (K850396)Roche Diagnostic Systems, Inc.1985-02-27
CRITIC-ARS (K844709)Dimension Diagnostics1985-01-08
GEMCAL ENI REFERENCE SERUM (K844344)Biocell Laboratories, Inc.1985-01-03
REFERRIL CALIBRATORS (K844585)Instrumentation Laboratory CO1984-12-11
SERACON TM SR III (K844027)Bhp Diagnostix, Inc.1984-11-27
SERACON TM SR IV (K844026)Bhp Diagnostix, Inc.1984-11-27
DOUMENT TM LINEARITY TEST STANDARDS (K843947)Casco Standards1984-10-17
CHANGES IN THE CHEMICAL COMP. OF 5 (K841464)Nova Biomedical Corp.1984-06-22
VENTREXYME EIA CONTROLS IMMUNOASSAY (K841456)Vxr, Inc.1984-05-21
SODIUM & POTASSIUM STANDARD SOLUT (K841419)Reagent Laboratory, Inc.1984-05-11
SODIUM & POTASSIUM STANDARD SOL 80 (K841420)Reagent Laboratory, Inc.1984-05-11
HDL CHOLESTEROL CONTROLS-LEVELS (K840278)Preventive Diagnostics Corp.1984-03-23
TRIGLYCERIDE/CHOLESTEROL AQUEOUS (K840219)Preventive Diagnostics Corp.1984-03-23
PARAMAX BILIRUBIN CALIBRATORS (K833005)American Dade1983-11-14
LYPHOCHEK SERUM REF. STANDARD-BOVINE (K832695)Bio-Rad1983-10-04
SERALYZER MULTICOMPONENT CALIBRATORS (K832046)Miles Laboratories, Inc.1983-08-11
COBAS STANDARDS FOR GLUCOSE & BUN (K831030)Roche Diagnostic Systems, Inc.1983-05-09
SALT BRIDGE SOLUTION & URINE DILUENT (K830341)Shaban Mfg. Co.1983-03-10
KM-KAL L3 (K823044)Kmn Products, Inc.1982-12-09
KM-KAL L4 (K823045)Kmn Products, Inc.1982-11-05
KM-KAL L2 (K823043)Kmn Products, Inc.1982-11-05
KM-KAL L5 (K823046)Kmn Products, Inc.1982-11-05
GLUCOSE/UREA NITROGEN STANDARD (K822937)Emd Chemicals, Inc.1982-11-05
KM-KAL L1 (K823042)Kmn Products, Inc.1982-11-05
CO2/CI STANDARDS (K822289)Gilford Diagnostics1982-08-24
REF. ELECTRODE SOL'N.;STANDARD B (K821885)Avl Scientific Corp.1982-07-13
NOVA V FLUIDS PACK & EXTERNAL STANDARDS (K821794)Shaban Mfg. Co.1982-07-02
NOVA IV FLUIDS PACK & EXTERNAL STANDARDS (K821623)Shaban Mfg. Co.1982-06-14
NOVA II FLUIDS PACK (K821030)Shaban Mfg. Co.1982-05-03
NOVA III FLUIDS PACK (K820947)Shaban Mfg. Co.1982-04-26
NOVA I FLUIDS PACK (K820701)Shaban Mfg. Co.1982-04-01
EXTERNAL STANDARDS-SODIUMNPOTASSIUM (K820700)Shaban Mfg. Co.1982-04-01
SODIUM & POTASSIUM PRODUCTS (K813127)Alko Diagnostic Corp.1982-01-22
DOCUMENT LINEARITY TEST STANDARDS (K813411)North American Standards1981-12-18
BECKMAN ICS CALIBRATOR (K812649)Beckman Instruments, Inc.1981-10-19
HITACHI 705 CALIBRATOR (K811921)Boehringer Mannheim Corp.1981-07-23
BIO SET TM PHOSPHOROUS CALIBRATOR (K810964)Boehringer Mannheim Corp.1981-04-17
FLAME PHOTOMETRY REAGENTS (K803051)Laboratory Products, Inc.1981-01-09
COMBUNED CALCIUM AND PHOSPHORUS STD. (K802824)Mallinckrodt Critical Care1980-12-11
BUN/GLUCOSE STANDARDS (K802633)Gilford Diagnostics1980-12-11
COMBINED GLUCOSE AND BUN STANDARDS (K802825)Mallinckrodt Critical Care1980-12-11
ALBUMIN/TOTAL PROTEIN STANDARDS (K802632)Gilford Diagnostics1980-12-11
CENTRIFICHEM COMB. SERUM-BASED CALIB. (K802741)Union Carbide Corp.1980-12-10
REAGENTS FOR ASTRA 8 AUTOMATED ANALYZER (K801222)Simmler, Inc.1980-06-26
GAL-PUT CONTROLS, NORMAL&DEFICIENT (K800910)Sigma Chemical Co.1980-04-29
CESIUM DILUENT (1.5 MM/L) (K800043)Gilford Diagnostics1980-01-21
SODIUM/POTASSIUM 140/5 MEQ/L) (K800041)Gilford Diagnostics1980-01-21
SODIUM/POTASSIUM (100/100 MEQ/E) (K800040)Gilford Diagnostics1980-01-21
SERACON-SRI (PROD. # D029 (K792486)Bhp Diagnostix, Inc.1979-12-31
SERACON-SRI (K792485)Bhp Diagnostix, Inc.1979-12-31
SERACON-SRII (K792487)Bhp Diagnostix, Inc.1979-12-31
PRINCIPAL ANALYTE REFERENCE SERUM (K792384)Beckman Instruments, Inc.1979-12-06
LANCER L-INA HUMAN REFERENCE SERUM (K792013)Sherwood Medical Industries1979-11-13
CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD (K791874)Gilford Diagnostics1979-10-17
SERACON CAL D025 (K791956)Bhp Diagnostix, Inc.1979-10-11
CALIBRATOR I (K791693)Hi Chem, Inc.1979-09-17
CALIBRATOR II (K791694)Hi Chem, Inc.1979-09-17
SERACON-N (K782039)Bhp Diagnostix, Inc.1979-02-26
SERACON-A (K782037)Bhp Diagnostix, Inc.1979-02-08
SERACON-SRII (K781758)Bhp Diagnostix, Inc.1978-12-04
SERACON-SRI (K781757)Bhp Diagnostix, Inc.1978-12-04
CALIBRATOR, BOVINE SERUM (K781702)Bio-Reagents & Diagnostics, Inc.1978-11-15
COMP. CLIN. CHEM. REF. SERUM-BENCHMARK (K780553)Beckman Instruments, Inc.1978-05-19
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL A (K770010)Hyland Therapeutic Div., Travenol Laboratories1977-04-18
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL B (K770011)Hyland Therapeutic Div., Travenol Laboratories1977-04-18
Q-PAK CHEMISTRY RADIORECEPTOR CONTROL C (K770012)Hyland Therapeutic Div., Travenol Laboratories1977-04-18
BLOOD GAS ANALYZER-CALIBRATION GAS (K770494)Gardner Cryogenics1977-04-15
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