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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

Decided510(k)Device and applicantCode
Feb 17, 1988K875282QM300 CALIBRATOR B PACK
Kallestad Diag, A Div. of Erbamont, Inc.
JIX
Feb 3, 1988K875304BIOTROL CALIBRANT LEVEL 2
Biotrol, USA, Inc.
JIX
Feb 2, 1988K875318BIOTROL CALIBRANT LEVEL 3
Biotrol, USA, Inc.
JIX
Feb 2, 1988K875288BIOTROL CALIBRANT LEVEL 1
Biotrol, USA, Inc.
JIX
Jan 5, 1988K874587PARAMAX URINE/CSF CALIBRATOR
Baxter Healthcare Corp
JIX
Jan 5, 1988K874413REAGENT A AND REAGENT B
Seradyn, Inc.
JIX
Nov 23, 1987K871755PROTEIN STANDARD CALIBRATOR
Wako Chemicals USA, Inc.
JIX
Sep 2, 1987K873118BIOTROL REFERENCE
Biotrol, USA, Inc.
JIX
Sep 2, 1987K873116MULTI ANALYTE MIXTURES, CALIBRATORS
Biotrol, USA, Inc.
JIX
Sep 2, 1987K872789PARAMAX URINE/CSF CALIBRATOR
American Dade
JIX
May 28, 1987K871184FLAME PHOTOMETER STANDARD #60083 160 NA/8K
In Vitro Diagnostics, Inc.
JIX
May 28, 1987K871183FLAME PHOTOMETER STANDARD #60082 140 NA/5K
In Vitro Diagnostics, Inc.
JIX
May 28, 1987K871182FLAME PHOTOMETER STANDARD #60081 120 NA/2K
In Vitro Diagnostics, Inc.
JIX
May 21, 1987K871341QM300 CALIBRATOR A PACK
Kallestad Diag, A Div. of Erbamont, Inc.
JIX
May 12, 1987K871638EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
Em Diagnostic Systems, Inc.
JIX
May 8, 1987K871664IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR
Instrumentation Laboratory CO
JIX
Feb 13, 1987K864909DU PONT LIQUID MULTI-ANALYTE CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIX
Oct 21, 1986K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/L
Reagent Laboratory, Inc.
JIX
Sep 29, 1986K863489PARAMAX ELECTROLYTE CALIBRATOR
American Dade
JIX
Sep 26, 1986K863095ACE II (TRI-LEVEL)
Medical Analysis Systems, Inc.
JIX
Aug 19, 1986K862594SERACON(TM) CAL (PRODUCT NO. DO35)
Bhp Diagnostix, Inc.
JIX
Aug 4, 1986K862703EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95
Em Diagnostic Systems, Inc.
JIX
Jul 29, 1986K861786DU PONT DRUG CALIBRATOR
E.I. Dupont DE Nemours & Co., Inc.
JIX
Apr 7, 1986K860765EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
Em Diagnostic Systems, Inc.
JIX
Mar 14, 1986K855014QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A
Kallestad Laboratories, Inc.
JIX
Feb 19, 1986K855199PARAMAX COMPREHENSIVE CALIBRATOR
American Dade
JIX
Oct 25, 1985K854092DMA CALIBRATORS
Data Medical Associates, Inc.
JIX
Jun 25, 1985K851990INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU
Alpkem Corp.
JIX
Jun 14, 1985K851939CORNING CERTAIN -ISE
Corning Medical & Scientific
JIX
May 20, 1985K851151FISHER DIAGNOSTICS KDA CALIBRATOR II
Fisher Scientific Co., LLC
JIX
May 20, 1985K851150FISHER DIAGNOSTICS KDA CALIBRATOR I
Fisher Scientific Co., LLC
JIX
May 10, 1985K850859COBAS CALIBRATOR SERUM
Roche Diagnostic Systems, Inc.
JIX
Apr 1, 1985K850405CALIBRATOR B 88133
Hi Chem, Inc.
JIX
Feb 27, 1985K850396ROCHE STANDARDS FOR CHLORIDE & CO2
Roche Diagnostic Systems, Inc.
JIX
Jan 8, 1985K844709CRITIC-ARS
Dimension Diagnostics
JIX
Jan 3, 1985K844344GEMCAL ENI REFERENCE SERUM
Biocell Laboratories, Inc.
JIX
Dec 11, 1984K844585REFERRIL CALIBRATORS
Instrumentation Laboratory CO
JIX
Nov 27, 1984K844027SERACON TM SR III
Bhp Diagnostix, Inc.
JIX
Nov 27, 1984K844026SERACON TM SR IV
Bhp Diagnostix, Inc.
JIX
Oct 17, 1984K843947DOUMENT TM LINEARITY TEST STANDARDS
Casco Standards
JIX
Jun 22, 1984K841464CHANGES IN THE CHEMICAL COMP. OF 5
Nova Biomedical Corp.
JIX
May 21, 1984K841456VENTREXYME EIA CONTROLS IMMUNOASSAY
Vxr, Inc.
JIX
May 11, 1984K841420SODIUM & POTASSIUM STANDARD SOL 80
Reagent Laboratory, Inc.
JIX
May 11, 1984K841419SODIUM & POTASSIUM STANDARD SOLUT
Reagent Laboratory, Inc.
JIX
Mar 23, 1984K840278HDL CHOLESTEROL CONTROLS-LEVELS
Preventive Diagnostics Corp.
JIX
Mar 23, 1984K840219TRIGLYCERIDE/CHOLESTEROL AQUEOUS
Preventive Diagnostics Corp.
JIX
Nov 14, 1983K833005PARAMAX BILIRUBIN CALIBRATORS
American Dade
JIX
Oct 4, 1983K832695LYPHOCHEK SERUM REF. STANDARD-BOVINE
Bio-Rad
JIX
Aug 11, 1983K832046SERALYZER MULTICOMPONENT CALIBRATORS
Miles Laboratories, Inc.
JIX
May 9, 1983K831030COBAS STANDARDS FOR GLUCOSE & BUN
Roche Diagnostic Systems, Inc.
JIX

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