meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
51
Latest Decision
1999-06-21

Clearances · page 37 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K990654 QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT Quantase , Ltd. JIA Class I 1999-06-21
K990644 QUANTASE TOTAL GALACTOSE SCREENING ASSAY Quantase , Ltd. JIA Class I 1999-06-21
K990250 HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 Morax LBT Class I 1999-06-18
K990581 DIRECT HDL-CHOLESTEROL REAGENT Kamiya Biomedical Co. LBS Class I 1999-06-18
K991692 CHIRON DIAGNOSTICS ACS: 180 FT3 Chiron Diagnostics Corp. CDP Class II 1999-06-18
K991498 ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL Neometrics, Inc. JIA Class I 1999-06-16
K991447 CARDIOQUANT CARDIAC ASSESSMENT CONTROLS Spectral Diagnostics, Inc. JJY Class I 1999-06-11
K991166 K-ASSAY MICROALBUMIN CALIBRATOR SET Kamiya Biomedical Co. JIX Class II 1999-06-10
K991795 IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 Diagnostic Products Corp. MMI Class II 1999-06-09
K991797 IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 Diagnostic Products Corp. JHX Class II 1999-06-09
K990658 THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY Little Nell Labs, Inc. JLW Class II 1999-06-02
K991432 BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 Biocheck, Inc. KLI Class II 1999-06-02
K991311 TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 Biocheck, Inc. CDP Class II 1999-06-02
K991181 MODIFICATION OF N PROTEIN STANDARD SL Dade Behring, Inc. JIX Class II 1999-06-01
K991299 MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI Princeton BioMeditech Corp. JHT Class II 1999-05-28
K991175 MODIFICATION TO ALCYON DIRECT BILIRUBIN Abbott Laboratories CIG Class II 1999-05-28
K991515 INSURE PREGNANCY TEST Inbios Intl., Inc. DHA Class II 1999-05-28
K991430 SMARTPREP CENTRIFUGE SYSTEM Harvest Technologies, LLC JQC Class I 1999-05-28
K990247 MTM BIOSCANNER HDL, MODEL # BSA450, BSA460, BSA470 Polymer Technology Systems, Inc. LBR Class I 1999-05-28
K991088 VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE Becton Dickinson Vacutainer Systems JKA Class II 1999-05-28
K991156 GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM Great Smokies Diagnostic Laboratory JOC Class I 1999-05-28
K991108 CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 A.P. Total Care, Inc. KHS Class II 1999-05-25
K990980 BUN, MODEL BU 104-01 A.P. Total Care, Inc. CDQ Class II 1999-05-25
K991109 CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02 A.P. Total Care, Inc. CGX Class II 1999-05-25
K991111 BUFFER CHROMOGEN (R1), PRODUCT NO. CA110-01, EDTA REAGEN (R2), PRODUCT NO. CA110-02 A.P. Total Care, Inc. CIC Class II 1999-05-25
K991386 EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) Selfcare, Inc. CEP Class I 1999-05-25
K991247 URIC ACID, MODEL UA112-01 A.P. Total Care, Inc. KNK Class I 1999-05-25
K991466 EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) Selfcare, Inc. CEP Class I 1999-05-25
K990981 GLUCOSE, HEXOKINASE (R1), MODEL GL101-01, GLUCOSE HEXOKINASE (R2), MODEL GL101-02 A.P. Total Care, Inc. CFR Class II 1999-05-25
K990978 ALBUMIN BCG, MODEL AL 103-01 A.P. Total Care, Inc. CJW Class II 1999-05-25
K991244 TOTAL IRON, MODELS FE 109-01, FE 109-02 A.P. Total Care, Inc. JMO Class I 1999-05-25
K984261 SURESTEP BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc. CGA Class II 1999-05-21
K990346 BAYER ADVIA 1650 CHEMISTRY SYSTEM Bayer Corp. JGS Class II 1999-05-21
K991182 MODIFICATION OF N/T PROTEIN CONTROL SL Dade Behring, Inc. JJY Class I 1999-05-19
K991010 ACP Abbott Diagnostics Mfg., Inc. CKB Class II 1999-05-19
K991387 ELAN ALKALINE PHOSPHATE REAGENT KIT Elan Holdings, Inc. CJE Class II 1999-05-19
K991120 VACUTAINER BRAND CTAD TUBE (MULTIPLE) Becton Dickinson Vacutainer Systems JKA Class II 1999-05-19
K990016 VITROS IMMUNODIAGNOSTIC PRODUCTS ANEMIA CONTROLS Ortho-Clinical Diagnostics, Inc. JJY Class I 1999-05-19
K991252 AIA-PACK FT3 ASSAY Tosoh Medics, Inc. CDP Class II 1999-05-11
K990073 CALCITONIN Kmi Diagnostics, Inc. JKR Class II 1999-05-11
K990684 MODIFICATION OF SAS SERUM/URINE HCG Sa Scientific, Inc. JHI Class II 1999-05-10
K991075 ATLAST GLUCOSE CONTROL SOLUTION Amira Medical, Inc. JJX Class I 1999-05-10
K990741 SAS ONE-STEP PREGNANCY Sa Scientific, Inc. JHI Class II 1999-05-10
K991369 ACCUDIP HOME PREGNANCY AND/OR AIMSTICK PREGNANCY Germaine Laboratories, Inc. LCX Class II 1999-05-10
K991193 SAS HCG-CHECK Sa Scientific, Inc. LCX Class II 1999-05-04
K984527 IN TOUCH DIABETES MANAGEMENT SOFTWARE Lifescan, Inc. CGA Class II 1999-04-29
K991095 QUICKCARD HCG COMBO TEST, MODEL #9014 Phamatech JHI Class II 1999-04-28
K990971 EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 Medica Corp. JJR Class I 1999-04-27
K990610 ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 Bio-Rad JJY Class I 1999-04-27
K991067 MODIFICATION OF: DAVIDSTRIP HCG Simex Medical, Inc. JHI Class II 1999-04-27
K990754 CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 Diagnostic Chemicals , Ltd. KHS Class II 1999-04-20
K990939 FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM Selfcare, Inc. CGA Class II 1999-04-20
K990434 CARESIDE CKMB Careside, Inc. JHS Class II 1999-04-19
K990439 CARESIDE CK Careside, Inc. JHS Class II 1999-04-19
K990824 REVISED C-REACTIVE PROTEIN CALIBRATOR Dade Behring, Inc. JIT Class II 1999-04-16
K990827 MICROPLATE NEONATAL GALT ASSAY Bio-Rad KQP Class II 1999-04-09
K990984 VITROS IMMUNODIAGNOSTIC PRODUCTS CEA RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. JJX Class I 1999-04-08
K990888 MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 Bio-Rad JJY Class I 1999-04-07
K990262 CLEARPLAN EASY HOME PREGNANCY TEST Unipath , Ltd. LCX Class II 1999-04-07
K990424 ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 Bio-Rad JJY Class I 1999-03-31
K990608 ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 Bio-Rad JJX Class I 1999-03-30
K990783 VITROS IMMUNODIAGNOSTIC PRODUCTS CA15-3 RANGE VERIFIERS, CA125 II RANGE VERIFIERS, PSA RANGE VERIFIERS Ortho-Clinical Diagnostics, Inc. JJX Class I 1999-03-25
K984494 RANDOX ALBUMIN Randox Laboratories, Ltd. CIX Class II 1999-03-23
K990554 DIMENSION SPECIAL PROTEIN CALIBRATOR Dade Behring, Inc. JIT Class II 1999-03-22
K990460 CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) Roche Diagnostics Corp. JIX Class II 1999-03-22
K990393 ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 Bio-Rad JJX Class I 1999-03-22
K990249 OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 Phamatech CEP Class I 1999-03-22
K990755 SAS HCG URINE CONTROLS Sa Scientific, Inc. JJX Class I 1999-03-19
K990720 SAS HCG SERUM CONTROLS Sa Scientific, Inc. JJX Class I 1999-03-19
K990317 ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 Bio-Rad JJY Class I 1999-03-18
K984006 GLUCOMETER ELITE XL BLOOD GLUCOSE METER Bayer Corp. CGA Class II 1999-03-18
K990036 CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000 Careside, Inc. JGS Class II 1999-03-18
K990394 ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 Bio-Rad JJY Class I 1999-03-18
K990009 CARESIDE AST Careside, Inc. CIT Class II 1999-03-16
K990391 ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 Bio-Rad JJY Class I 1999-03-15
K990531 VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS Ortho-Clinical Diagnostics, Inc. JJY Class I 1999-03-12
K990282 ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 Bio-Rad JJY Class I 1999-03-09
K990578 OSOM CARD II HCG-URINE TEST, MODEL 102 Wyntek Diagnostics, Inc. JHI Class II 1999-03-09
K990576 OSOM CARD PREGNANCY TEST, MODEL 103 Wyntek Diagnostics, Inc. LCX Class II 1999-03-09
K983071 BILICHEK NON-INVASIVE BILIRUBIN ANALYZER Respironics, Inc. MQM Class I 1999-03-04
K981865 MTM BIOSCANNER K TEST STRIPS Polymer Technology Systems, Inc. JMK Class I 1999-02-26
K990222 IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 Diagnostic Products Corp. DHA Class II 1999-02-26
K990223 MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR Unipath , Ltd. NGE Class I 1999-02-24
K990373 FACT PLUS ONE STEP PREGNANCY TEST Abbott Laboratories LCX Class II 1999-02-22
K984076 INSTANT-VIEW PREGNANCY URINE TEST Alfa Scientific Designs, Inc. JHI Class II 1999-02-16
K984080 INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST Alfa Scientific Designs, Inc. JHI Class II 1999-02-16
K983070 CK Abbott Laboratories CGS Class II 1999-02-16
K984077 INSTANT-VIEW PREGNANCY COMBO TEST Alfa Scientific Designs, Inc. JHI Class II 1999-02-16
K990216 MAGNETIC TIBC KIT Reference Diagnostics, Inc. JMO Class I 1999-02-16
K984463 QUANTASE PHE/GAL SCREENING ASSAY Quantase , Ltd. JNB Class II 1999-02-16
K984079 INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST Alfa Scientific Designs, Inc. JHI Class II 1999-02-16
K984075 INSTANT-VIEW PREGNANCY URINE MID-STREAM TEST Alfa Scientific Designs, Inc. LCX Class II 1999-02-16
K984574 INFINITY GLUCOSE REAGENT Sigma Diagnostics, Inc. CFR Class II 1999-02-11
K982003 DS30 HCY HOMOCYSTEINE ASSAY KIT Drew Scientific , Ltd. LPS Class II 1999-02-11
K990025 CARESIDE AMYLASE Careside, Inc. JFJ Class II 1999-02-08
K984520 NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 Nichols Institute Diagnostics CGR Class II 1999-02-05
K984166 VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE REAGENT PACK 1/2, VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12/FOLATE REAGENT P3 Ortho-Clinical Diagnostics, Inc. CGN Class II 1999-02-05
K984301 ABBOTT ARCHITECT FOLATE Abbott Laboratories CGN Class II 1999-02-05
K983047 ACCU-CHEK HQ SYSTEM Boehringer Mannheim Corp. LFR Class II 1999-02-05
K984108 ABBOTT ARCHITECT B12 Abbott Laboratories LIG Class II 1999-02-03

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