meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
59
Latest Decision
1989-10-12

Clearances · page 72 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K894476 CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION Catachem, Inc. CJY Class II 1989-10-12
K894579 CLEARPLAN EASY Unipath , Ltd. CEP Class I 1989-10-12
K895102 BIOTRACK PDS MONITOR Biotrack, Inc. JJQ Class I 1989-10-10
K893205 FIRST CHOICE (TM) Polymer Technology Corp. CGA Class II 1989-10-06
K895128 BIOTRACK ALT TEST CARTRIDGE Biotrack, Inc. CJJ Class I 1989-10-06
K895105 HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE Waters Chemical Products DPM Class I 1989-10-06
K895181 ABL500 BLOOD GAS SYSTEM Radiometer America, Inc. CHL Class II 1989-10-06
K894420 ORTHO RESULT PLUS/PREGNANCY Ortho Diagnostic Systems, Inc. JHI Class II 1989-10-04
K894204 CALCIUM (ARSENAZO III) REAGENT Sigma Diagnostics, Inc. CJY Class II 1989-10-04
K895423 ACCESS CHEMISTRY ANALYZER American Monitor Corp. JJE Class I 1989-10-04
K892665 PRO-JECT(TM) SAFETY NEEDLE HOLDER Pro-Tec Containers, Inc. JKA Class II 1989-10-04
K895240 DELFIA PLATE FLUOROMETER 1232 Pharmacia, Inc. KHO Class I 1989-10-04
K895582 QCLYTE PROTEIN-BASED ISE CONTROL Baxter Healthcare Corp JJR Class I 1989-10-04
K894575 TECHNICON RA SYSTEM THYROXINE T4 METHOD Technicon Instruments Corp. CDX Class II 1989-10-04
K894394 ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT Abbott Laboratories CFR Class II 1989-10-03
K895158 VISION WHOLE BLOOD HDL CHOLESTEROL Abbott Laboratories CHH Class I 1989-10-02
K893718 DELTATEST (R) LIPASE II Electro-Nucleonics, Inc. CET Class I 1989-09-28
K894518 FPR AMIKACIN CALIBRATOR KIT Colony Laboratories, Inc. DLG Class I 1989-09-28
K894524 FPR GENTAMICIN CALIBRATOR KIT Colony Laboratories, Inc. DLG Class I 1989-09-28
K894222 TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL Abbott Laboratories JJE Class I 1989-09-28
K894852 SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS Instrumentation Laboratory CO JJY Class I 1989-09-28
K894804 SINGLE (SPECIFIED) ANALYTE CONTROL (ASSAYED) Lifescan, Inc. JJX Class I 1989-09-28
K894310 AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730) American Research Products Co. CDT Class I 1989-09-28
K895277 ORTHO APO B ELISA TEST SYSTEM Medical Marketing Consultants, Inc. MSJ Class I 1989-09-27
K894182 IMX TOTAL B-HCG Abbott Laboratories JHI Class II 1989-09-26
K894528 FPR PHENYTOIN CALIBRATOR KIT Colony Laboratories, Inc. DLG Class I 1989-09-25
K894407 ABBOTT SPECTRUM(R) CALCIUM REAGENT Abbott Laboratories CIC Class II 1989-09-25
K894200 FREE T3 RADIOIMMUNOASSAY KIT Advanced Magnetics, Inc. CDP Class II 1989-09-25
K894169 BIOTEL MICROALBUMINURIA (TM) American Diagnostic Corp. JIR Class I 1989-09-18
K894605 DELFIA FREE THYROXINE (FT4) KIT Pharmacia, Inc. CEC Class II 1989-09-18
K895003 MILENIA(TM) PROLACTIN (MKPR1,5) Diagnostic Products Corp. CFT Class I 1989-09-18
K894509 BICARBONATE TEST ITEM NUMBER: 65412 Em Diagnostic Systems, Inc. KHS Class II 1989-09-15
K894180 ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) Abbott Laboratories CIT Class II 1989-09-13
K894585 REP TM SPE (PONCEAU S) PROCEDURES Helena Laboratories CEF Class I 1989-09-13
K894761 TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. CGJ Class I 1989-09-13
K894049 IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. JLS Class I 1989-09-08
K894483 GLUCOSE-HK TEST (GLU-HK) ITEM #65415 Em Diagnostic Systems, Inc. CFR Class II 1989-09-07
K894265 DSL 17A-OH PROGERSTERONE (DSL #6800) Diagnostic Systems Laboratories, Inc. JLX Class I 1989-09-07
K884970 PINSET Safety Diagnostics, Inc. JKA Class II 1989-09-07
K894482 LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 Em Diagnostic Systems, Inc. CFJ Class II 1989-09-07
K893811 SAKURA PREP AI AUTOMATIC LIQUID HANDLING SYSTEM Sakura Finetek U.S.A., Inc. JQW Class I 1989-09-07
K894218 NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM Nova Biomedical Corp. JGS Class II 1989-09-07
K894063 TRIGLYCERIDE (GPO) TRINDER REAGENT Sigma Diagnostics, Inc. JGY Class I 1989-09-07
K894101 ROCHE REAGENT FOR URIC ACID Roche Diagnostic Systems, Inc. KNK Class I 1989-09-05
K893778 CALCIUM TEST ITEM NUMBER: 65409 Em Diagnostic Systems, Inc. CIC Class II 1989-09-05
K894503 GEMTAB SYSTEM Pharmacia Eni Diagnostics, Inc. JJQ Class I 1989-09-05
K894173 BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT Catachem, Inc. CDQ Class II 1989-09-05
K894145 EMIT T-UPTAKE ASSAY Syva Co. KHQ Class II 1989-09-05
K894329 RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL Amersham Corp. JJX Class I 1989-09-05
K894408 ABBOTT TESTPACK PLUS HCG URINE Abbott Laboratories JHI Class II 1989-09-05
K894081 ROCHO ISOMUNE - LD Roche Diagnostic Systems, Inc. CFE Class II 1989-08-31
K894378 UREA NITROGEN TEST (BUN) ITEM #65408 Em Diagnostic Systems, Inc. CDQ Class II 1989-08-31
K893691 EMDS CREATINE KINASE ITEM NIMBER 65411 Diagnostic Systems CGS Class II 1989-08-31
K893915 EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 Em Diagnostic Systems, Inc. CEK Class II 1989-08-31
K894057 QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT Photec Diagnostics, Inc. LBS Class I 1989-08-31
K894710 DPC-ROBOSTAT(TM) Diagnostic Products Corp. JQW Class I 1989-08-31
K893838 MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER Ciba Corning Diagnostics Corp. JQP Class I 1989-08-31
K894508 MAGNESIUM TEST ITEM NUMBER: 65419 Em Diagnostic Systems, Inc. JGJ Class I 1989-08-31
K894366 REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 Helena Laboratories LBT Class I 1989-08-31
K894181 POSITIVE AND NEGATIVE HCG URINE CONTROLS Armkel, LLC JJX Class I 1989-08-31
K894687 DYNATECH MR 5000, CATALOG #011-976-0600 Dynatech Laboratories, Inc. JJQ Class I 1989-08-31
K894288 PHOSPHORUS TEST ITEM NUMBER 65416 Em Diagnostic Systems, Inc. CED Class I 1989-08-31
K893917 EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 Em Diagnostic Systems, Inc. CDT Class I 1989-08-28
K893916 EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 Em Diagnostic Systems, Inc. CHH Class I 1989-08-28
K893613 STATSPIN MINI-PLASMA Statspin Technologies JKA Class II 1989-08-28
K894207 CK-MB/LD-1 CONTROL SYSTEM Boehringer Mannheim Corp. JJT Class I 1989-08-28
K894287 URIC ACID TEST ITEM NUMBER 65422 Em Diagnostic Systems, Inc. KNK Class I 1989-08-28
K894069 ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER Abbott Laboratories JQW Class I 1989-08-21
K894272 DENLEY WELLDILL 3 Denley Instruments, Inc. JQW Class I 1989-08-21
K894141 LIQUID CHROMATOGRAPHY COLUMNS Supelco, Inc. DPM Class I 1989-08-21
K893692 EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 Diagnostic Systems CIT Class II 1989-08-21
K893873 SINGLE AND DUAL BAND DIPSTICK HCG TEST Ampcor, Inc. DHA Class II 1989-08-21
K894270 DENLEY ANTHOS 2001 READER Denley Instruments, Inc. JJQ Class I 1989-08-21
K893777 ALBUMIN TEST (ALB) ITEM NUMBER: 65401 Em Diagnostic Systems, Inc. CIX Class II 1989-08-21
K893976 COAT-A-COUNT (TM) FSH IRMA Diagnostic Products Corp. CGJ Class I 1989-08-17
K893751 AMYLASE TEST (AML) ITEM NUMBER: 65404 Em Diagnostic Systems, Inc. JFJ Class II 1989-08-17
K893953 ABSOLUTE(TM)-HCG URINE PREGNANCY TEST Totem Diagnostics, Inc. DHA Class II 1989-08-15
K891241 ABBOTT SPECTRUM AMYLASE REAGENT Abbott Laboratories JFJ Class II 1989-08-15
K892801 CLINISTAT TOTAL BILIRUBIN REAGENT TEST Heraeus Kulzer, Inc. CIG Class II 1989-08-15
K893469 AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT Amersham Corp. CEE Class II 1989-08-15
K894279 LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST Bd Becton Dickinson Vacutainer Systems Preanalytic CEP Class I 1989-08-15
K894126 ROBOTIC SAMPLE PROCESSOR Tecan U.S., Ltd. JQW Class I 1989-08-15
K894271 DENLEY WELLWASH 2 AND 4 Denley Instruments, Inc. JQW Class I 1989-08-15
K890295 TARGET(TM) CK-MB V-Tech, Inc. JHY Class II 1989-08-15
K893768 MODIFIED PK300 AUTOMATIC EIA ANALYZER Olympus Corp. JJF Class I 1989-08-15
K891999 CHLORIDE STANDARDS ITEM #SR1041 Em Diagnostic Systems, Inc. JIT Class II 1989-08-15
K894078 LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II Bio-Rad JJY Class I 1989-08-11
K893628 OLYMPUS ISE MODULE FOR AU5000 Olympus Corp. CGZ Class II 1989-08-11
K893738 QUIDEL REFLECTANCE ANALYZER Quidel Corp. JJQ Class I 1989-08-11
K893620 T3 CLASP-BEAD EIA KIT Biotecx Laboratories, Inc. CDP Class II 1989-08-11
K893973 ROCHE REAGENT FOR TRIGLYCERIDES Roche Diagnostic Systems, Inc. CDT Class I 1989-08-11
K893730 DIRECT BILIRUBIN REAGENT Medical Analysis Systems, Inc. CIG Class II 1989-08-11
K893137 EXCEL (TM) CHEMISTRY ANALYZER American Monitor Corp. JJE Class I 1989-08-10
K891061 BIOTROL CALCIUM MONOREACTIF Biotrol, USA, Inc. CJY Class II 1989-08-10
K892060 CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM Syva Co. JQP Class I 1989-08-10
K893508 PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI Baxter Healthcare Corp JFH Class II 1989-08-04
K894327 EMIT D.A.U. LOW & MEDIUM CALIBRATOR A Syva Co. DKG Class I 1989-08-03
K893548 SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP Heraeus Kulzer, Inc. LBS Class I 1989-08-03
K893577 STATUS HCG FLUOROMETRIC ENZYME Baxter Healthcare Corp DHA Class II 1989-08-03
K894091 AMERLEX-MAB FT4 KIT Amersham Corp. CEC Class II 1989-08-03

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.