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JJY

673 FDA 510(k) clearances · Product code

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RecordFirmDate
ANALYZER: STAT PROFILE PLUS 10 ANALYZER (K931373)Nova Biomedical Corp.1993-06-15
DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET (K931139)Casco Standards1993-05-12
ELECTROPHORESIS CONTROL LEVEL 1 (K925326)Seradyn, Inc.1993-03-26
CALIBRATION VERIFICATION KIT OR CVK (K924802)Radiometer America, Inc.1993-03-09
QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL (K925256)Quantimetrix Corp.1993-03-01
CANCER ANTIGEN CONTROL (K924061)Polymedco, Inc.1993-02-23
DADE(R) CK-MB/MYOGLOBIN IMMUN CONTROL, I,II,III (K926046)Baxter Diagnostics, Inc.1993-01-05
SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 (K924915)Helena Laboratories1992-12-18
DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET (K923795)Casco Standards1992-11-05
I-STAT(TM) LEVELS 1,2,3 CONTROLS (K921477)I-Stat Corp.1992-11-02
MULTIQUAL UNASSAYED PRODUCTS (K923632)Ciba Corning Diagnostics Corp.1992-10-13
MULTIQUAL ASSAY PRODUCTS (K923633)Ciba Corning Diagnostics Corp.1992-10-13
KODAK AMERLITE TOTAL THYROID CONTROL SERA (K923740)Eastman Kodak Company1992-09-25
MONI-TROL-L AND MONI-TROL-XL (K920291)Medical Analysis Systems, Inc.1992-09-02
AMERLITE FREE THYROID CONTROL SERA LAN.4002 (K923165)Eastman Kodak Company1992-08-10
LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 (K922046)Bio-Rad1992-07-10
DADE URINE CHEMISTRY CONTROL LEVELS I AND II (K920636)Baxter Diagnostics, Inc.1992-07-07
KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 (K920927)Helena Laboratories1992-06-19
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 (K921286)Bio-Rad1992-06-09
KEMTROL SERUM CONTROL-ABNORMAL (K920926)Helena Laboratories1992-05-07
AMERLITE FREE THYROID CONTROL SERA LAN.4002 (K920940)Eastman Kodak Company1992-04-17
HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL (K920826)Eastman Kodak Company1992-04-07
CHEM-CHEM MULTI-ANALYTE (MODIFIED) (K920350)Streck Laboratories, Inc.1992-03-23
RIATRAC PLUS (K914958)Becton Dickinson Advanced Diagnostics1992-03-18
TRI-POINT LIQUIMMUNE LIGAND CONTROL LEVELS 1,2,3 (K914204)Medical Analysis Systems, Inc.1992-03-17
N/T PROTEIN CONTROL UY (K914890)Behring Diagnostics, Inc.1992-02-06
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 (K914255)Bio-Rad1992-01-09
RAI-TROL ELEVATED LIPIDS CONTROL (K915191)Reagents Applications, Inc.1991-12-18
CVM (K914619)Ciba Corning Diagnostics Corp.1991-11-22
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) (K913133)Bionostics, Inc.1991-09-27
LIPID LINEARITY CONTROLS (K913224)Creative Laboratory Products, Inc.1991-09-25
CHEM-CHEX (K913687)Streck Laboratories, Inc.1991-09-19
ENZYME LINEARITY CONTROL (K912718)Phoenix Diagnostics, Inc.1991-09-06
DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL (K912455)Baxter Healthcare Corp1991-08-12
TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL (K912725)Creative Laboratory Products, Inc.1991-07-30
LINEARITY TEST KITS (K912441)Boehringer Mannheim Corp.1991-07-17
ANEMIA I, II (K911984)Ciba Corning Diagnostics Corp.1991-06-13
DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL (K911854)Baxter Healthcare Corp1991-06-10
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE (K911755)Bionostics, Inc.1991-05-22
HI CHEM AQUEOUS MULTIANALYTE LINE STAND, MODIFIED (K911803)Hichem Diagnostics1991-05-15
DOCUMENT REFLECTANCE II LINEARITY TEST SET (K910440)Casco Standards1991-05-10
ACS THERAPEUTIC DRUG MONIT CONTR, SET II, LEVEL I (K911169)Analytical Control Systems, Inc.1991-05-01
ACS THERAPEUTIC DRUG MONIT CONTR, SET II LEVEL III (K911171)Analytical Control Systems, Inc.1991-05-01
CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II (K904989)Creative Laboratory Products, Inc.1991-01-23
CHEM-CHEX LIPID (K905389)Streck Laboratories, Inc.1990-12-26
CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL (K904781)Cholestrech Corp.1990-12-18
CHOLESTECH L.D.X. LEVEL 1 CONTROL (K904784)Cholestech Corp.1990-12-18
HDL CHOLESTEROL CONTROL (K904872)Analytical Control Systems, Inc.1990-12-07
LDL-DIRECT CONTROLS (K902740)Isolab, Inc.1990-12-07
ACS CHOLESTEROL/TRIGLYCERIDE LIQUID CONTROL (K904829)Analytical Control Systems, Inc.1990-12-06
QCLYTE PROTEIN BASED ISE CONTROL (K904968)Baxter Healthcare Corp1990-12-06
CLINICAL CHEMISTRY CONTROL (K904075)Phoenix Diagnostics, Inc.1990-12-06
KODATROL I AND II CONTROL AND DILUENT SET (K904768)Eastman Kodak Company1990-11-09
TDM PLUS XL ENHANCED LIQ DRUG CONTROL I,II,III (K904141)Medical Analysis Systems, Inc.1990-11-01
URIC ACID/IRON/MAGNESIUM LINEARITY STANDARDS (K904099)Hichem Diagnostics1990-10-26
HI CHEM BILIRUBIN LINEARITY SET (PRODUCT #88237) (K904293)Hichem Diagnostics1990-10-12
DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2 (K903933)Baxter Healthcare Corp1990-10-04
DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III (K903566)Baxter Healthcare Corp1990-09-24
CHALLENGE(TM) BRAND LIQ MULTI-ANALYTE LINEAR CONTR (K903310)Medical Analysis Systems, Inc.1990-09-07
KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL (K903338)Kenlor Industries, Inc.1990-09-07
AFFINITY HLH TEST SYSTEM (K903407)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-09-07
CLP LOW LEVEL HDL CHOLESTEROL -LIPID CONTROL (K902909)Creative Laboratory Products, Inc.1990-08-22
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY (K903190)Medical Analysis Systems, Inc.1990-08-17
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT (K903225)Medical Analysis Systems, Inc.1990-08-17
BILIRUBIN CONTROL (K902616)Phoenix Diagnostics, Inc.1990-07-19
BLOOD GAS/ISE CONTROLS (K902094)Phoenix Diagnostics, Inc.1990-07-19
LVM QUALITY CONTROL SERUM (K902235)Ciba Corning Diagnostics Corp.1990-07-17
HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STND (K902673)Hi Chem, Inc.1990-07-17
PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM (K902536)Boehringer Mannheim Corp.1990-07-10
PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM (K902573)Boehringer Mannheim Corp.1990-07-10
BLOOD GAS/ELECTROLYTE/CO-OXIMETER CONTROLS (K902095)Phoenix Diagnostics, Inc.1990-06-12
DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET (K901988)Casco Standards1990-05-31
LIG/TDM A, B, C (K901212)Ciba Corning Diagnostics Corp.1990-05-01
TECHNICON TESTPOINT(TM) LIGAND CONTROL (K900717)Technicon Instruments Corp.1990-04-26
MULTICONSTITUENT SERUM RANGE LINEARITY #88234 (K901115)Hichem Diagnostics1990-04-19
CHEM-CHEX (K900993)Streck Laboratories, Inc.1990-04-16
DADE(R) TDM CONTROL (K892642)Baxter Healthcare Corp1990-02-02
CLP NORMAL LIPID CONTROL (K895862)Creative Laboratory Products, Inc.1990-01-19
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3 (K895905)Bio-Rad1990-01-18
CLP COMPREHENSIVE LIPID CONTROL-LR (K896246)Creative Laboratory Products, Inc.1990-01-10
CLP COMPREHENSIVE LIPID CONTROL-HR (K896247)Creative Laboratory Products, Inc.1990-01-10
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY (K896522)Casco Standards1990-01-02
NORMAL AND ABNORMAL CONTROL SERA (K895943)Sclavo, Inc.1989-12-27
SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS (K894852)Instrumentation Laboratory CO1989-09-28
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II (K894078)Bio-Rad1989-08-11
LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM (K894252)Bio-Rad1989-08-01
DADE LIPID-TROL (K893580)Baxter Healthcare Corp1989-07-20
DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET (K893141)Casco Standards1989-06-23
DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET (K893142)Casco Standards1989-06-23
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II (K891680)Bio-Rad1989-06-13
MONI-TROL(R) (K891929)Baxter Healthcare Corp1989-05-09
AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) (K890708)Amersham Corp.1989-03-20
RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) (K890414)Amersham Corp.1989-03-15
RIATRAC PLUS (K890470)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-03-15
KENLOR HUMAN SPINAL FLUID CONTROL LIQUID (K890576)Kenlor Industries, Inc.1989-03-09
SHAPE-ACTIO URINALYSIS CONTROLS (K890442)Actio, Inc.1989-03-08
GAS TRAK PLUS (K884977)United Diagnostics, Inc.1989-01-27
HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL (K883942)Icl Scientific1988-11-10
LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II (K882486)Bio-Rad1988-10-25
DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST (K883861)Casco Standards1988-10-13
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