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Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
PANCREATIC A-AMYLASE EPS (K895880)Boehringer Mannheim Corp.1989-12-19
AUTOSCAN, AUTOSTRIP AND AUTOCONTROL (K896144)Cascade Medical, Inc.1989-12-19
COBAS READY (K896007)Roche Diagnostic Systems, Inc.1989-12-19
AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 (K896270)Amersham Corp.1989-12-12
CALCIUM AND PH ELECTROLYTE ANALYZER (K895397)Ionetics, Inc.1989-12-12
MODIFIED CEDIA(TM) CORTISOL ASSAY (K896451)Microgenics Corp.1989-12-12
CALCIUM, CATALOGUE NUMBER140-20 (K895873)Diagnostic Chemicals, Ltd. (Usa)1989-12-12
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER (K895936)Medica Corp.1989-12-12
CHOLESTEROL, UNIVERSAL ET (K896073)Enzyme Technology, Inc.1989-12-12
D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. (K896329)Photec Diagnostics, Inc.1989-12-12
CORTISOL TEST SYSTEM (K895421)Baxter Healthcare Corp1989-12-07
URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS (K895821)Catachem, Inc.1989-12-05
SYNCHRON CX SYSTEMS (LAP) REAGENT KIT (K895850)Beckman Instruments, Inc.1989-12-05
MILENIA(TM) HCG (MKCG1,5) (K895809)Diagnostic Products Corp.1989-12-01
IMMUNOCARD HCG II-S TEST KIT (K895912)Disease Detection International, Inc.1989-12-01
ISOSCREEN-CK CONFIRMATORY KIT (K895870)Roche Diagnostic Systems, Inc.1989-12-01
MODIFIED MODEL 535(TM) LUMINOMETER (K896117)Los Alamos Diagnostics1989-11-30
SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT (K895851)Beckman Instruments, Inc.1989-11-29
STATSPIN STATSAMPLER (K896206)Statspin Technologies1989-11-22
DSL I-PTH (DSL #8000) (K896294)Diagnostic Systems Laboratories, Inc.1989-11-21
FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT (K896222)Nichols Institute Diagnostics1989-11-17
PROTOFLUOR Z (K893038)Helena Laboratories1989-11-17
TOTAL BILIRUBIN L.F. (K895822)Sclavo, Inc.1989-11-14
QUANTIMETRIX BILIRUBIN CALIBRATORS (K895778)Quantimetrix Medical Industries1989-11-14
GLUCOSE-HEXOKINASE REAGENTS 4470030,050,300,600 (K896028)American Research Products Co.1989-11-14
TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD (K895664)Technicon Instruments Corp.1989-11-14
HI CHEM TRIGLYCERIDES CALIBRATOR E (88185) (K895585)Hichem Diagnostics1989-11-13
ALANINE AMINOTRANSFERASE (ALT) (K896001)American Monitor Corp.1989-11-13
MODIFIED HOMECLINIC PREGNANCY TEST (K895560)Vanguard Biomedical Corp.1989-11-13
CARDS O.S. (TM) HCG-URINE (K895390)Pacific Biotech, Inc.1989-11-13
WAKO(TM) AUTOKIT GAMMA-GT (K895984)Wako Chemicals USA, Inc.1989-11-08
CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS (K894715)Catachem, Inc.1989-11-08
HDL SINGLES (K895381)Trace America, Inc.1989-11-08
FIAGEN T3 UPTAKE CATALOGUE #101-402 (K895186)Cyberfluor, Inc.1989-11-08
QUANTAI UG REAGENT STRIP (K893661)Quantai Biotronics, Inc.1989-11-08
ONE TOUCH II METER (K895911)Lifescan, Inc.1989-11-08
SANISERV SURGICAL SLUSH SYSTEM (K894006)Saniserv, Inc.1989-11-03
CYBERFLUOR FIAGEN TSH (K895396)Cyberfluor, Inc.1989-10-31
IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) (K895723)Diagnostic Products Corp.1989-10-31
MILENIA(TM) FSH (MKFS1,5) (K895005)Diagnostic Products Corp.1989-10-31
DOUBLE ANTIBODY GLUCAGON (K893975)Diagnostic Products Corp.1989-10-31
OSMOMETER STANDARD SOLUTIONS (K892329)D.R.G. Scientific Industries1989-10-31
SYSTEMATE(TM) IRON ITEM NUMBER: 65417 (K895249)Em Diagnostic Systems, Inc.1989-10-31
HVA EIA KIT YAMASA (K895288)Yamasa Shoy Co., Ltd.1989-10-31
EOS CHEMISTRY ANALYZER (K894035)Eos Technology Corp.1989-10-31
TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT (K895094)Hybritech, Inc.1989-10-31
LP 400 MICROPLATE READER (K894859)Kallestad Diag, A Div. of Erbamont, Inc.1989-10-31
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 (K895250)Em Diagnostic Systems, Inc.1989-10-31
ABBOTT TDX TOTAL T3 PLUS (K894238)Abbott Laboratories1989-10-31
CEDIA CORTISOL ASSAY (K893954)Microgenics Corp.1989-10-31
FASTEC 901 AGGLUTINATION PATTERN READER (K895967)Schiff & Co.1989-10-30
DART UREA NITROGEN (K894836)Coulter Electronics, Inc.1989-10-30
VMA EIA KIT YAMASA (K895287)Yamasa Shoy Co., Ltd.1989-10-30
CIBA CORNING CERTAIN LYTE (K894576)Ciba Corning Diagnostics Corp.1989-10-30
CREATININE 340 (ENZYMATIC) (K895847)Sclavo, Inc.1989-10-30
PHENYLALANINE (NINHYDRIN REACTION) (K891070)Alpkem Corp.1989-10-27
BUN (KINETIC) (K895666)Boehringer Mannheim Corp.1989-10-27
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD (K895672)Technicon Instruments Corp.1989-10-25
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 (K895528)Helena Laboratories1989-10-25
PLASMA CATECHOLAMINES BY HPLC (K894966)Bio-Rad1989-10-25
COAT-A-COUNT (TM) HCG IRMA (K894941)Diagnostic Products Corp.1989-10-25
QUIDEL HCG TEST (K894790)Quidel Corp.1989-10-25
FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. (K895108)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-23
URIC ACID PAP (K895665)Boehringer Mannheim Corp.1989-10-23
SYSTEMATE CREATININE TEST (CREA) #65413 (K895022)Em Diagnostic Systems, Inc.1989-10-23
MICRO-PLATE READER, MDX-1 (K894400)Medix Biotech, Inc.1989-10-23
MILENIA(TM) CORTISOL (MKCO1,5) (K895006)Diagnostic Products Corp.1989-10-23
HI CHEM CALIBRATOR A+ (K895135)Hichem Diagnostics1989-10-23
CLINISTAT LDH REAGENT TEST (K895138)Heraeus Kulzer, Inc.1989-10-19
LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER (K895718)Data Medical Associates, Inc.1989-10-19
CORTISOL CLASP-BEAD EIA KIT (K895407)Biotecx Laboratories, Inc.1989-10-19
MILENIA(TM) TOTAL T4 (MKT41,5) (K895840)Diagnostic Products Corp.1989-10-19
BIOSPOT HCG-RAPID PREGNANCY TEST (K894705)Princeton Biomedix1989-10-18
BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (K894750)Princeton Biomedix1989-10-18
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY (K895380)Serono-Baker Diagnostics, Inc.1989-10-17
IQ LDH (K894578)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-10-17
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER (K895313)Dynatech Laboratories, Inc.1989-10-17
CLINISTAT POTASSIUM REAGENT TEST (K895047)Heraeus Kulzer, Inc.1989-10-17
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 (K895119)Em Diagnostic Systems, Inc.1989-10-17
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407 (K895118)Em Diagnostic Systems, Inc.1989-10-17
SOURCERER (K894902)Oakfield Instruments, Ltd.1989-10-17
CLP CK/LD ISOENZYME CONTROL (K894554)Creative Laboratory Products, Inc.1989-10-16
MODEL 100 PORTABLE CLINICAL ANALYZER AND TEST PACK (K894914)I-Stat Corp.1989-10-16
COBAS READY GLUCOSE REAGENT (K895526)Roche Diagnostic Systems, Inc.1989-10-16
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. (K894993)Baxter Healthcare Corp1989-10-13
CLEARPLAN EASY (K894579)Unipath , Ltd.1989-10-12
CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY (K894988)Ciba Corning Diagnostics Corp.1989-10-12
CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION (K894476)Catachem, Inc.1989-10-12
BIOTRACK PDS MONITOR (K895102)Biotrack, Inc.1989-10-10
FIRST CHOICE (TM) (K893205)Polymer Technology Corp.1989-10-06
HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE (K895105)Waters Chemical Products1989-10-06
BIOTRACK ALT TEST CARTRIDGE (K895128)Biotrack, Inc.1989-10-06
ABL500 BLOOD GAS SYSTEM (K895181)Radiometer America, Inc.1989-10-06
DELFIA PLATE FLUOROMETER 1232 (K895240)Pharmacia, Inc.1989-10-04
PRO-JECT(TM) SAFETY NEEDLE HOLDER (K892665)Pro-Tec Containers, Inc.1989-10-04
ACCESS CHEMISTRY ANALYZER (K895423)American Monitor Corp.1989-10-04
QCLYTE PROTEIN-BASED ISE CONTROL (K895582)Baxter Healthcare Corp1989-10-04
TECHNICON RA SYSTEM THYROXINE T4 METHOD (K894575)Technicon Instruments Corp.1989-10-04
CALCIUM (ARSENAZO III) REAGENT (K894204)Sigma Diagnostics, Inc.1989-10-04
ORTHO RESULT PLUS/PREGNANCY (K894420)Ortho Diagnostic Systems, Inc.1989-10-04
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