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Clinical Chemistry

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

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RecordFirmDate
ACID PHOSPHATASE (ACP) REAGENT (K863851)Sigma Diagnostics, Inc.1986-10-16
CHLORIDE PROCEDURE (K863585)Data Medical Associates, Inc.1986-10-16
FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM (K863678)Nichols Institute Diagnostics1986-10-16
GSC 1000 (K863566)Genetic Systems Corp.1986-10-16
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM (K863679)Nichols Institute Diagnostics1986-10-16
CIBA CORNING PRISMA T4 LIPIA (LIPOSOME) (K862233)Ciba Corning Diagnostics Corp.1986-10-14
PEAK OVULATION PREDICTOR (K863121)Micron Technology, Inc.1986-10-14
PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT (K862447)Pantex, Div. Bio-Analysis, Inc.1986-10-07
ABNORMAL SPINAL FLUID CONTROL (K863745)Ciba Corning Diagnostics Corp.1986-10-07
TDX(R) AMYLASE II (K863622)Abbott Laboratories1986-10-03
CREATINE PHOSPHOKINASE(CK) PROCEDURE (K863587)Data Medical Associates, Inc.1986-10-03
BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS (K861255)Behring Diagnostics, Inc.1986-10-03
BEHRING RAPIMAT II (K861263)Behring Diagnostics, Inc.1986-10-03
LACTATE DEHYDROGENASE(LD) PROCEDURE (K863255)Data Medical Associates, Inc.1986-10-03
GAMMA GLUTAMYL TRANSFERASE PROCEDURE (K863586)Data Medical Associates, Inc.1986-10-03
CREATININE PROCEDURE (K863261)Data Medical Associates, Inc.1986-10-02
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 (K863425)American Research Products Co.1986-10-01
PROLACTIN RIABEAD II DIAGNOSTIC KIT (K863240)Abbott Laboratories1986-09-29
AMYLASE PROCEDURE (K863588)Data Medical Associates, Inc.1986-09-29
HDL/CHOLESTEROL TEST SYSTEM (K861244)Chrometrics Laboratories, Inc.1986-09-29
PREGNASLIDE (K863198)Armkel, LLC1986-09-29
TOTAL PROTEIN PROCEDURE (K863258)Data Medical Associates, Inc.1986-09-29
OLYMPUS AU 5000 FLAME PHOTOMETER MODULE (K862148)Olympus Corp.1986-09-29
AMYLASE SR LIQUID STABLE REAGENT SET (K862733)Medical Analysis Systems, Inc.1986-09-29
ALKALINE PHOSPHATASE PROCEDURE (K863268)Data Medical Associates, Inc.1986-09-29
POTASSIUM TEST (K863486)Sclavo, Inc.1986-09-29
CHOLESTEROL PROCEDURE (K863252)Data Medical Associates, Inc.1986-09-29
URIC ACID (URICASE) METHOD-II (K863287)Catachem, Inc.1986-09-29
PARAMAX ELECTROLYTE CALIBRATOR (K863489)American Dade1986-09-29
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95 (K863544)Em Diagnostic Systems, Inc.1986-09-29
AVL ISE-TROL ELECTROLYTE CONTROL (K863333)Avl Scientific Corp.1986-09-29
NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER (K863438)Nova Biomedical Corp.1986-09-29
ACE II (TRI-LEVEL) (K863095)Medical Analysis Systems, Inc.1986-09-26
TRIGLYCERIDE (TRINDER) PROCEDURE (K863254)Data Medical Associates, Inc.1986-09-26
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 (K863477)Em Diagnostic Systems, Inc.1986-09-26
RAICHEM(TM) CHLORIDE REAGENT (K863620)Reagents Applications, Inc.1986-09-26
URIC ACID PROCEDURE (K863251)Data Medical Associates, Inc.1986-09-26
CALCIOMETER (K863059)J. D. Assoc.1986-09-26
DEMAND TOTAL PROTEIN (K863301)Cooper Biomedical, Inc.1986-09-26
BILIRUBIN TOTAL DIRECT (K863057)J. D. Assoc.1986-09-26
ENZLIPASE, ENZYMATIC LIPASE KIT (K862312)Nuclear Diagnostics, Inc.1986-09-26
AST/GOT PROCEDURE (K863257)Data Medical Associates, Inc.1986-09-26
TRIGLYCERIDES-E (K863075)J. D. Assoc.1986-09-26
CALCIUM PROCEDURE (K863256)Data Medical Associates, Inc.1986-09-26
ALKALINE PHOSPHATASE TEST (K862498)King Diagnostics, Inc.1986-09-26
DELFIA(TM) CORTISOL KIT (K863422)Lkb Instruments, Inc.1986-09-26
GLUCOSE HK PROCEDURE (K863259)Data Medical Associates, Inc.1986-09-26
HPL RIA KIT (K863188)Biotecx Laboratories, Inc.1986-09-25
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 (K863545)Em Diagnostic Systems, Inc.1986-09-25
RSL (125I) ALDOSTERONE KIT (K862204)Radioassay Systems Laboratories, Inc.1986-09-25
PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT (K862336)Pantex, Div. Bio-Analysis, Inc.1986-09-25
ABBOTT SPECTRUM PHOSPHORUS REAGENT (K863088)Abbott Laboratories1986-09-25
CHOLESTEROL-E (TOTAL) (K863062)J. D. Assoc.1986-09-25
FREE T3 RADIOIMMUNOASSAY KIT (K862968)Bioclinical Group1986-09-25
ALBUMIN (BCP) (K863226)Sigma Diagnostics, Inc.1986-09-17
TOTAL BILIRUBIN PROCEDURE (K863262)Data Medical Associates, Inc.1986-09-17
EMDS(TM) ALBUMIN TESTPACKS, #67652/95 (K863004)Em Diagnostic Systems, Inc.1986-09-16
VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) (K861449)Exel Intl.1986-09-16
ALT/GPT PROCEDURE (K863253)Data Medical Associates, Inc.1986-09-16
FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT (K862813)Serono Diagnostics, Inc.1986-09-16
ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT (K863099)Abbott Laboratories1986-09-16
QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL (K861420)Quantimetrix Corp.1986-09-16
RIGHT-DAY OVULATION HOME TEST (K861354)Leeco Diagnostics, Inc.1986-09-16
EMDS(TM) CALCIUM TESTPACKS, #67687/95 (K863003)Em Diagnostic Systems, Inc.1986-09-16
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 (K863426)American Research Products Co.1986-09-16
ABBOTT TESTPACK (TM) HCG SERUM (K863032)Abbott Laboratories1986-09-15
TESTPACK ACUTE HCG URINGE CONTROLS (K863127)Abbott Laboratories1986-09-15
THERAPEUTIC DRUG MONITORING CONTROL SET (K862963)American Monitor Corp.1986-09-15
ULTRASCAN CLINICAL ANALYZER (K862999)Specialty Medical Industries, Inc.1986-09-15
CARDS(TM) HCG-URINE (K863199)Pacific Biotech, Inc.1986-09-15
AKERSCAN COLORIMETRIC ANALYZER (K862908)Akers Medical Technologies1986-09-15
ALBUMIN PROCEDURE (K863263)Data Medical Associates, Inc.1986-09-15
TESTPACK ACUTE HCG SERUM CONTROLS (K863126)Abbott Laboratories1986-09-15
INORGANIC PHOSPHORUS PROCEDURE (K863264)Data Medical Associates, Inc.1986-09-11
ALBUMETER (K863050)J. D. Assoc.1986-09-11
FAST MUCOPROTEINS (K863070)J. D. Assoc.1986-09-11
MAGNESIUM PROCEDURE (K863267)Data Medical Associates, Inc.1986-09-11
CHOLESTEROL-E (FREE) (K863064)J. D. Assoc.1986-09-11
IRON PROCEDURE (K863266)Data Medical Associates, Inc.1986-09-11
CHOLESTEROL-E FAST (TOTAL) (K863063)J. D. Assoc.1986-09-09
CREATININE-E (K863078)J. D. Assoc.1986-09-09
ALP S.C.E. (K863051)J. D. Assoc.1986-09-09
TOTAL LIPIDS (K863073)J. D. Assoc.1986-09-09
UREAFAST (K863076)J. D. Assoc.1986-09-09
PHOSPHOLIPIDS-E (K863071)J. D. Assoc.1986-09-09
TOTAL PROTEINS (K863074)J. D. Assoc.1986-09-09
ALPHA AMYLASE (K863052)J. D. Assoc.1986-09-09
BILIFAST (K863055)J. D. Assoc.1986-09-09
BLOOD UREA NITROGEN(BUN) PROCEDURE (K863260)Data Medical Associates, Inc.1986-09-09
FOSFOROMETER (K863072)J. D. Assoc.1986-09-09
URICMETER (K863113)J. D. Assoc.1986-09-09
AMYLASE LTS (K862640)Electro-Nucleonics Laboratories, Inc.1986-09-09
CLOROFAST (K863061)J. D. Assoc.1986-09-09
CIBA CORNING MAGIC LITE ANALYZER (K862235)Ciba Corning Diagnostics Corp.1986-09-08
ENZYMATIC BLOOD GLUCOSE (K862721)U. S. Diagnostics, Inc.1986-09-03
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 (K863005)Em Diagnostic Systems, Inc.1986-08-29
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 (K862845)Em Diagnostic Systems, Inc.1986-08-29
ALP (OPT) REAGENT (K862905)Sigma Diagnostics, Inc.1986-08-29
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET (K860682)Gambro, Inc.1986-08-29
AVL MODEL 984 ELECTROLYTE ANALYZER (K862819)Avl Scientific Corp.1986-08-29
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