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Clinical Chemistry

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

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RecordFirmDate
CLP CK/LD ISOENZYME/IMMUNO CONTROL (K896465)Creative Laboratory Products, Inc.1990-03-01
FIAGEN(TM) HLH.S (K900621)Cyberfluor, Inc.1990-03-01
ENZYMUN TEST(R) TBK (K896991)Boehringer Mannheim Corp.1990-03-01
COULTER URIC ACID REAGENT (K897161)Coulter Electronics, Inc.1990-03-01
ABBOTT COMMANDER PARALLEL PROCESSING CENTER (K897158)Abbott Laboratories1990-03-01
LYTENING 2Z LYTENING SYSTEM 31 (K900300)Baxter Healthcare Corp1990-03-01
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781 (K900250)American Research Products Co.1990-03-01
MODIFIED DSL-2300 ACTH RIA (K900147)Diagnostic Systems Laboratories, Inc.1990-03-01
BICARBONATE REAGENTS PRODUCT #7713 & #7714 (K900420)American Research Products Co.1990-03-01
SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM (K897110)Medisense, Inc.1990-02-27
DIRECT BILIRUBIN REAGENT (K900259)Medical Analysis Systems, Inc.1990-02-27
COBAS READY ALBUMIN REAGENT (K896235)Roche Diagnostic Systems, Inc.1990-02-27
COBAS READY TOTAL BILIRUBIN REAGENT (K896232)Roche Diagnostic Systems, Inc.1990-02-27
COBAS READY BUN REAGENT (K896236)Roche Diagnostic Systems, Inc.1990-02-27
AUTOREADER CALIBRATION TEST PLATE (K900579)Bio-Tek Instruments, Inc.1990-02-27
POSITIVE AND NEGATIVE HCG SERUM CONTROLS (K896875)Armkel, LLC1990-02-26
1400 SERIES EVIDENCE COLLECTION KIT (K896373)Transidyne General Corp.1990-02-26
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 (K900251)Helena Laboratories1990-02-26
SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM (K896951)Medisense, Inc.1990-02-26
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT (K897150)Toyo Jozo Co., Ltd.1990-02-26
COULTER AST (GOT) REAGENT (K897165)Coulter Electronics, Inc.1990-02-23
THYROID STIMULATING HORMONE-EIA-XT (K896867)In Vitro Diagnostics, Inc.1990-02-23
BIOTRACK IMMUNOCHEMISTRY MONITOR (K900372)Biotrack, Inc.1990-02-23
COULTER TOTAL PROTEIN REAGENT (K897166)Coulter Electronics, Inc.1990-02-23
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT (K897169)Photec Diagnostics, Inc.1990-02-23
ABBOTT SPECTRUM URIC ACID REAGENT KIT (K896954)Abbott Laboratories1990-02-23
TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) (K896829)Technicon Instruments Corp.1990-02-23
CARBON DIOXIDE REAGENT (K896812)Pointe Scientific, Inc.,1990-02-23
COBAS READY PROFILE 1 REAGENT STRIP (K896229)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY STAT PROFILE REAGENT STRIP (K896234)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY ALT REAGENT (K896237)Roche Diagnostic Systems, Inc.1990-02-16
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT (K896587)Medix Biotech, Inc.1990-02-16
CHOLESTEROL TEST KIT (K895951)Elite Technology, Inc.1990-02-16
COBAS READY TRIGLYCERIDE REAGENT (K896231)Roche Diagnostic Systems, Inc.1990-02-16
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT (K896845)Reagents Applications, Inc.1990-02-16
KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT (K896440)Kenlor Industries, Inc.1990-02-16
COBAS READY URIC ACID REAGENT (K896227)Roche Diagnostic Systems, Inc.1990-02-16
CENTRIPREP 100 (K900280)Amicon, Inc.1990-02-16
COBAS READY TOTAL PROTEIN REAGENT (K896230)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY AST REAGENT (K896238)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY CHOLESTEROL REAGENT (K896239)Roche Diagnostic Systems, Inc.1990-02-16
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 (K896170)Helena Laboratories1990-02-16
COBAS READY CARDIO PROFILE REAGENT STRIP (K896228)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY LDH REAGENT (K896241)Roche Diagnostic Systems, Inc.1990-02-16
COBAS READY LIVER PROFILE REAGENT STRIP (K896233)Roche Diagnostic Systems, Inc.1990-02-16
MODIFIED PARAMAX URIC ACID REAGENT (K896521)Baxter Healthcare Corp1990-02-16
COBAS READY CK REAGENT (K896240)Roche Diagnostic Systems, Inc.1990-02-16
CO2 REAGENT (340 NM) (K896258)Sigma Chemical Co.1990-02-13
LUTEINIZING HORMONE-EIA-XT (K896866)In Vitro Diagnostics, Inc.1990-02-13
EOS IONIZED CALCIUM TEST CARD (K896316)Eos Technology Corp.1990-02-13
ENZYMUN TEST R T3 (K896900)Boehringer Mannheim Corp.1990-02-08
COULTER PHOSPHORUS REAGENT (K900215)Coulter Corp.1990-02-08
AMYLASE REAGENT (K896650)Sigma Chemical Co.1990-02-08
AMRESCO CREATININE REAGENT #4316100 (K896686)American Research Products Co.1990-02-08
COULTER ALP (ALK PHOS) REAGENT (K900216)Coulter Corp.1990-02-08
ENZYMUN TEST R HCG (K896901)Boehringer Mannheim Corp.1990-02-08
DADE(R) TDM CONTROL (K892642)Baxter Healthcare Corp1990-02-02
AVL MODEL 995HB PH/BLOOD GAS ANALYZER (K895317)Avl Scientific Corp.1990-02-01
CARBON DIOXIDE REAGENT (K896590)Pointe Scientific, Inc.,1990-02-01
MODIFIED LH ENZYME IMMUNOASSAY TEST KIT (K896642)Medix Biotech, Inc.1990-01-30
VITRO T4-EIA-XT (K896865)In Vitro Diagnostics, Inc.1990-01-30
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER (K896514)Radiometer America, Inc.1990-01-23
ALLERCOAT MICROPLATE SYSTEM (K900028)Kallestad Diag, A Div. of Erbamont, Inc.1990-01-22
MILENIA (TM) TSH (K900014)Diagnostic Products Corp.1990-01-19
CLP NORMAL LIPID CONTROL (K895862)Creative Laboratory Products, Inc.1990-01-19
ABBOTT IMX PROLACTIN (K896162)Abbott Laboratories1990-01-19
CLINISTAT TOTAL PROTEIN REAGENT TEST (K896916)Heraeus Kulzer, Inc.1990-01-19
IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I (K896808)Nichols Institute Diagnostics1990-01-19
COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. (K895648)Ventrex Laboratories, Inc.1990-01-18
COATED TUBE HIGH SENSITIVITY TSH 200 UIU/ML STAN. (K895649)Ventrex Laboratories, Inc.1990-01-18
CLINISTAT ALBUMIN REAGENT TEST (K896910)Miles Diagnostics Div.1990-01-18
T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT (K896925)In Vitro Diagnostics, Inc.1990-01-18
LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3 (K895905)Bio-Rad1990-01-18
FOLLICLE STIMULATING HORMONE-EIA-XT (K896864)In Vitro Diagnostics, Inc.1990-01-11
PHOSPHORUS (K895999)American Monitor Corp.1990-01-11
SODIUM AND POTASSIUM STANDARD (K895717)Data Medical Associates, Inc.1990-01-11
ASPARTATE AMINOTRANFERASE (AST) (K896000)American Monitor Corp.1990-01-11
TRIGLYCERIDES TEST KIT (K895952)Elite Technology, Inc.1990-01-11
REP(TM) SPE PLUS-30 PROCEDURES (K896572)Helena Laboratories1990-01-11
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS (K896454)Boehringer Mannheim Corp.1990-01-11
TOTAL GALACTOSE (K894011)Alpkem Corp.1990-01-11
CLP COMPREHENSIVE LIPID CONTROL-LR (K896246)Creative Laboratory Products, Inc.1990-01-10
CHARISE CHARLES REAGENT STRIPS (K895282)Lee Import Domestic Consulting1990-01-10
CLP COMPREHENSIVE LIPID CONTROL-HR (K896247)Creative Laboratory Products, Inc.1990-01-10
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER (K896692)Baxter Healthcare Corp1990-01-02
MATRIX(TM)-96 (K896202)Canberra Industries, Inc.1990-01-02
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30 (K896526)Baxter Healthcare Corp1990-01-02
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT (K896640)Medix Biotech, Inc.1990-01-02
DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY (K896522)Casco Standards1990-01-02
HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 (K896643)Medix Biotech, Inc.1989-12-29
ACC.U.DIAL (K894423)Exocell, Inc.1989-12-27
MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT (K896641)Medix Biotech, Inc.1989-12-27
ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY (K896145)Serono-Baker Diagnostics, Inc.1989-12-27
MAGNET PAD (K896802)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
NORMAL AND ABNORMAL CONTROL SERA (K895943)Sclavo, Inc.1989-12-27
CLINISTAT HDL CHOLESTEROL REAGENT TEST (K895139)Heraeus Kulzer, Inc.1989-12-27
BECKMAN MA MICROALBUMIN REAGENT KIT (K895883)Beckman Instruments, Inc.1989-12-27
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) (K895555)Hichem Diagnostics1989-12-22
BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS (K895748)Catachem, Inc.1989-12-21
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY (K894175)Serono-Baker Diagnostics, Inc.1989-12-19
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