meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
56
Latest Decision
1985-04-30

Clearances · page 94 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K851253 TDX ANALYZER W/NEPHELOMETRY CAROUSEL Abbott Laboratories JQX Class I 1985-04-30
K851148 TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE Euro-Diagnostics BV JLW Class II 1985-04-29
K844679 DSL PAP RIA -DSL#3100 Diagnostic Systems Laboratories, Inc. JFH Class II 1985-04-29
K851330 PROLACTIN SYSTEM BY RIA American Bioclinical, Inc. CFT Class I 1985-04-29
K851043 SUGAR-CHEX II Streck Laboratories, Inc. JJX Class I 1985-04-29
K844735 PTH-RIA Syncor Intl. Corp. CEW Class II 1985-04-29
K851042 SUGAR-CHEX Streck Laboratories, Inc. JJX Class I 1985-04-29
K851350 ION 2 REAGENT KI Hi Chem, Inc. CEM Class II 1985-04-29
K851267 GEMENI AST-LTS REAGENTS Electro-Nucleonics Laboratories, Inc. CIT Class II 1985-04-29
K851234 A-JUST TURBIDITY METER Abbott Laboratories JQX Class I 1985-04-29
K851321 ATAC 2000 CHEMISTRY ANALYZER Turpen Laboratory Systems, Inc. JQP Class I 1985-04-25
K851239 ACTIVE DHEA-SULFATE DSL3500 Diagnostic Systems Laboratories, Inc. JKC Class I 1985-04-25
K851098 BEHRING VECTOR PHOTOMETER Behring Diagnostics, Inc. JJQ Class I 1985-04-25
K851308 ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S Technicon Instruments Corp. CIX Class II 1985-04-17
K850360 ESCHWEILER SYSTEM 2000 - GLOOD GAS ANALYZERS Text Tech Corp. CHL Class II 1985-04-17
K850949 MEDIX VISUAL URINE HCG (7/7) TEST Medix Biotech, Inc. JHI Class II 1985-04-12
K851071 PHARMACIA INSULIN RIA Pharmacia, Inc. CFP Class I 1985-04-12
K850574 DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO American Dade JJY Class I 1985-04-12
K850392 INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS Clinical Data, Inc. JJQ Class I 1985-04-12
K850575 DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H American Dade JJY Class I 1985-04-10
K851104 AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT Amersham Corp. CEP Class I 1985-04-10
K851079 BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3 Beckman Instruments, Inc. JJX Class I 1985-04-10
K850053 BACI 6 -ADRENOCORTICOTROOP HORMONE Euro-Diagnostics BV CKG Class II 1985-04-08
K850999 TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN Technicon Instruments Corp. JJF Class I 1985-04-08
K850987 MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM Medix Biotech, Inc. JHI Class II 1985-04-08
K850903 DATA ZYME CO2 PROCEDURE Data Medical Associates, Inc. KHS Class II 1985-04-08
K850604 PRECO PREGNANCY RAPID CARD TEST, HEM #2028 Preco, Inc. JHJ Class II 1985-04-08
K850748 I-L TEST, DIRECT BILIRUBIN SET Allied Instrumentation Laboratory CIG Class II 1985-04-03
K850254 PARATHYROID HORMONE RADIOIMMUNOASSAY KIT Cambridge Medical Technology CEW Class II 1985-04-03
K843908 ABBOTT TDT EIA Abbott Laboratories CIG Class II 1985-04-03
K850730 MODEL SERUM HCG ASSAY Monoclonal Antibodies, Inc. JHI Class II 1985-04-02
K850531 LEECO CONCEP-7-BHCG EIA Leeco Diagnostics, Inc. JHI Class II 1985-04-02
K850800 DROPSTIRS - PLASTIC DISPOSABLE PIPET Berwick Medical Products, Inc. JQW Class I 1985-04-02
K850570 STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY American Dade JHI Class II 1985-04-02
K850530 LEECO CONCEP-7-BHCG IRMA Leeco Diagnostics, Inc. JHI Class II 1985-04-02
K850405 CALIBRATOR B 88133 Hi Chem, Inc. JIX Class II 1985-04-01
K850901 DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE Data Medical Associates, Inc. CIG Class II 1985-04-01
K850986 DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE Data Medical Associates, Inc. CEO Class I 1985-04-01
K850659 SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER Syva Co. JQP Class I 1985-04-01
K850210 ISOENZYME TEST LD-1 Sclavo, Inc. CFE Class II 1985-03-29
K850054 RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI E.I. Dupont DE Nemours & Co., Inc. CIB Class II 1985-03-29
K843680 URI-VAL Cenogenics Corp. JMZ Class I 1985-03-29
K850787 SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY Nms Pharmaceuticals, Inc. CGI Class I 1985-03-26
K850963 DUPONT PREP TYPE SI EXTRACITON CARTRIDGE E.I. Dupont DE Nemours & Co., Inc. DJY Class I 1985-03-25
K850579 CUE FERTILITY MONITOR Zetek, Inc. NGE Class I 1985-03-22
K844567 TITERTEK TWINREADER 78-630-00 Flow Laboratories, Inc. JJQ Class I 1985-03-21
K844419 TITERTEK MULTISKAN MSS/340 Flow Laboratories, Inc. JJQ Class I 1985-03-21
K844418 TITERTEK MULTISKAN MCC Flow Laboratories, Inc. JJQ Class I 1985-03-21
K850882 ACTH II BY RADIOIMMUNOASSAY Immuno Nuclear Corp. CKG Class II 1985-03-21
K850902 DATA ZYME ACID PHOSPHATASE PROCEDURE Data Medical Associates, Inc. CKB Class II 1985-03-20
K850923 BUN (RATE) REAGENT Sigma Diagnostics, Inc. CDQ Class II 1985-03-20
K850788 GLUTAMYLTRANSFERASE ASSAY KIT Diagnostic Chemicals, Ltd. (Usa) JPZ Class I 1985-03-19
K844955 SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & Miles Laboratories, Inc. CEM Class II 1985-03-19
K850798 AMYLASE PRODUCTS Data Medical Associates, Inc. JFJ Class II 1985-03-14
K850334 ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS Roche Diagnostic Systems, Inc. CHJ Class II 1985-03-14
K850767 SPECTRONIC 2000 SPECTROPHOTOMETER Bausch & Lomb, Inc. JJQ Class I 1985-03-14
K850709 SPECTRONIC 501 & 601 - CLINICAL SPECTROPHOTOMETER Bausch & Lomb, Inc. JJQ Class I 1985-03-12
K850485 ROTOR SYSTEMS A/S-400 & LA/S-400 E.I. Dupont DE Nemours & Co., Inc. JQC Class I 1985-03-12
K850617 CORNING 780 FLUOROMETER/DENSITOMETER Corning Medical & Scientific JQT Class I 1985-03-12
K850348 UROTRON RL9 Boehringer Mannheim Corp. JJQ Class I 1985-03-12
K850708 SPECTRONIC 1001 - CLINICAL SPECTROPHOTOMETER Bausch & Lomb, Inc. JJQ Class I 1985-03-11
K850667 PERIDOCHROM TRIGLYCERIDES GPO Boehringer Mannheim Corp. CDT Class I 1985-03-11
K850272 WATERS 740 DATA MODULE-PLOTTER INTEGRATOR Millipore Corp. LDM Class I 1985-03-06
K850359 WATERS 460 LIQUID CHROMATOGRAPHY ELECTROCHEMICAL D Millipore Corp. LDM Class I 1985-03-05
K850017 PRECINORM H & PRECIPATH H Boehringer Mannheim Corp. JJY Class I 1985-03-05
K850639 ENZYMATIC ALPHA-AMYLASE REAGENT KIT Bio-Analytics Laboratories, Inc. CIW Class II 1985-03-05
K850364 GLUCOSE - TRINDER- REAGENT Sigma Chemical Co. CGA Class II 1985-03-05
K844583 TSH-STAT Nuclear Medical Laboratories, Inc. JLW Class II 1985-03-05
K850257 BCS GLUCOSE COLORIMETRIC TEST Bioclinical Systems, Inc. CGA Class II 1985-03-05
K850480 OVU STICK SELF-TEST -MODIFICATION Monoclonal Antibodies, Inc. CEP Class I 1985-03-05
K850213 ISOCONTROL SERUM CK-MB Sclavo, Inc. JJT Class I 1985-03-05
K850079 NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG Bioclinical Systems, Inc. LCX Class II 1985-03-05
K844135 PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU Immuno Nuclear Corp. CHO Class II 1985-03-05
K844965 LEUCINE AMINOPEPTIDASE REAGENT Alladin Diagnostic, Inc. JGG Class I 1985-03-05
K844346 FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES Fisher Diagnostics JHJ Class II 1985-03-04
K850159 TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT Hybritech, Inc. JHI Class II 1985-03-04
K850201 LEECO CONCEP-7-BHCG LEIAD II Leeco Diagnostics, Inc. JHI Class II 1985-03-04
K850376 TERUMO SENSIBEAD EIA TSH KIT Terumo Medical Corp. JLW Class II 1985-03-04
K850378 LDH REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CFJ Class II 1985-03-01
K844589 OSMOLARITY STANDARDS Rna Medical Corp. JMZ Class I 1985-03-01
K850381 MAGNESIUM REAGENT FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. JGJ Class I 1985-03-01
K850379 DIRECT BILIRUBIN FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CIG Class II 1985-03-01
K850380 INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER Advanced Biomedical Methods, Inc. CEO Class I 1985-03-01
K844848 IMA-TROL IMMUNOASSAY CONTROL Dimension Diagnostics JJY Class I 1985-03-01
K850383 PRL QUIK RIA KIT Pacific Biotech, Inc. CFT Class I 1985-03-01
K850396 ROCHE STANDARDS FOR CHLORIDE & CO2 Roche Diagnostic Systems, Inc. JIX Class II 1985-02-27
K850260 GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER Gelman Sciences, Inc. JQT Class I 1985-02-27
K844413 ULTROSER G Lkb Instruments, Inc. JJY Class I 1985-02-27
K844423 COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS Diagnostic Products Corp. CDZ Class I 1985-02-27
K850209 QUICK-LYTE Seragen Diagnostics, Inc. JGS Class II 1985-02-27
K844949 SYVA SAMPLE SEAL Syva Co. KIE Class I 1985-02-15
K844240 ENZYGNOST LIPASE TEST Behring Diagnostics, Inc. CET Class I 1985-02-12
K842474 GLUCOCHEK III Larken Industries, Inc. JJQ Class I 1985-02-12
K844914 ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN Abbott Laboratories JHJ Class II 1985-02-12
K850319 Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT Sigma Diagnostics, Inc. JQB Class I 1985-02-12
K850211 ISOCONTROL SERUM LD- Sclavo, Inc. JJT Class I 1985-02-07
K844968 EPICHROME PAP Cetus Corp. JFH Class II 1985-02-07
K850258 BCS POTASSIUM TURBIDIMETRIC TEST Bioclinical Systems, Inc. CEJ Class II 1985-02-07
K850212 ISOENZYME TEST CK-MB Sclavo, Inc. CGS Class II 1985-02-07
K850056 LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT Leeco Diagnostics, Inc. JLS Class I 1985-02-06

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