meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
57
Latest Decision
1992-10-19

Clearances · page 60 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K924658 OLYMPUS MAGNESIUM REAGENT Olympus Corp. JGJ Class I 1992-10-19
K922073 STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY Baxter Diagnostics, Inc. DHA Class II 1992-10-19
K924339 OLYMPUS AMYLASE REAGENT Olympus Corp. CIW Class II 1992-10-19
K924692 OLYMPUS CREATININE REAGENT Olympus Corp. CGX Class II 1992-10-19
K923511 CK-NAC ACTIVATED KIT Randox Laboratories, Ltd. CGS Class II 1992-10-15
K924429 OPUS(R) CK-MB Pb Diagnostic Systems, Inc. JHY Class II 1992-10-15
K924599 CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 Em Diagnostic Systems, Inc. CGX Class II 1992-10-15
K923571 VISTA TRIIODOTHYRONINE ASSAY Syva Co. CDP Class II 1992-10-15
K923048 ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM Boehringer Mannheim Corp. CGA Class II 1992-10-14
K924470 TWO PART INORGANIC PHOSPHORUS TEST Em Diagnostic Systems, Inc. CEO Class I 1992-10-14
K923598 REDI-CHECK PHOTMETER Q.A. Awareness Technology, Inc. JFS Class II 1992-10-14
K922771 KODAK AMERLEX MAB FT3 ASSAY Eastman Kodak Company CDP Class II 1992-10-14
K922945 TECHNICON DAX SYSTEM THYROXINE (T4) METHOD Heraeus Kulzer, Inc. CDX Class II 1992-10-14
K922943 NOVA NA/K/CL/LI MODULE Nova Biomedical Corp. CEM Class II 1992-10-13
K923633 MULTIQUAL ASSAY PRODUCTS Ciba Corning Diagnostics Corp. JJY Class I 1992-10-13
K923632 MULTIQUAL UNASSAYED PRODUCTS Ciba Corning Diagnostics Corp. JJY Class I 1992-10-13
K924704 CREATINE KINASE (CK) TEST ITEM #65411 Em Diagnostic Systems, Inc. CGS Class II 1992-10-13
K922969 KING DIAGNOSTICS UREA NITROGEN REAGENT King Diagnostics, Inc. CDN Class II 1992-10-13
K924475 ACCUDATA GLUCOSE TEST STATION Boehringer Mannheim Corp. CGA Class II 1992-10-13
K923456 MICROLITE MICROTITER PLATE LUMINOMETER ML3000 Dynatech Laboratories, Inc. JJQ Class I 1992-10-13
K923676 VISTA THYROXINE UPTAKE ASSAY Syva Co. KHQ Class II 1992-10-09
K922376 ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT Icn Biomedicals, Inc. CGJ Class I 1992-10-05
K922715 IMMUCHEM PRL-MW ELISA Icn Biomedicals, Inc. CFT Class I 1992-10-05
K922921 KING DIAGNOSTICS CHLORIDE REAGENT King Diagnostics, Inc. CHJ Class II 1992-10-05
K923609 OLYMPUS TOTAL BILIRUBIN REAGENT Olympus Corp. CIG Class II 1992-10-02
K923610 OLYMPUS CHLORIDE REAGENT Olympus Corp. CHJ Class II 1992-10-02
K923346 OLYMPUS AMYLASE REAGENT Olympus Corp. JFJ Class II 1992-10-02
K923376 VISUAL HCG PREGNANCY TEST Tech-Co, Inc. JHI Class II 1992-10-01
K923927 KING DIAGNOSTICS MAGNESIUM REAGENT King Diagnostics, Inc. JGJ Class I 1992-09-30
K922532 IL TEST GLUCOSE, PN 181633-80 Instrumentation Laboratory CO CGA Class II 1992-09-30
K924084 ATAC 6000 CHEMISTRY ANALYZER Bio-Chem Laboratory Systems, Inc. JJE Class I 1992-09-29
K923806 ANALYZER: NOVA 10 CRT ANALYZER & QUALI CONT MATER Nova Biomedical Corp. JGS Class II 1992-09-29
K922947 GAMMA GULTAMYL TRANSFERASE TEST Em Diagnostic Systems, Inc. JQB Class I 1992-09-28
K923257 EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 Em Diagnostic Systems, Inc. CKA Class I 1992-09-28
K923105 MILES URINE AMYLASE METHOD Heraeus Kulzer, Inc. JFJ Class II 1992-09-28
K923565 OLYMPUS IRON REAGENT Olympus Corp. JIY Class I 1992-09-28
K923527 OLYMPUS ALKALINE PHOSPHATASE REAGENT Olympus Corp. CJE Class II 1992-09-28
K923740 KODAK AMERLITE TOTAL THYROID CONTROL SERA Eastman Kodak Company JJY Class I 1992-09-25
K922035 GLUCOSE 3 Caro Med, Inc. CGA Class II 1992-09-23
K922699 DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR E.I. Dupont DE Nemours & Co., Inc. JIS Class II 1992-09-23
K923018 ENCORE TEST STRIPS Heraeus Kulzer, Inc. CFR Class II 1992-09-23
K921578 TITAN GEL ALKALINE PHOSPHATASE (HR) Helena Laboratories CIN Class II 1992-09-23
K923258 TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE Heraeus Kulzer, Inc. CDP Class II 1992-09-23
K923414 SYNERMED 600 NM URIC ACID REAGENT KIT Synermed, Inc. KNK Class I 1992-09-22
K924129 MILES AUTO METH DETERMIN OF URIC ACID IN URINE Heraeus Kulzer, Inc. KNK Class I 1992-09-22
K923342 MICROBACT SOLID PLATE SYSTEMS Radiometer America, Inc. JJS Class I 1992-09-22
K923764 SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 Em Diagnostic Systems, Inc. CEO Class I 1992-09-22
K923765 SYSTEMATE URICACID TEST, TECHNICON RA 1000 Em Diagnostic Systems, Inc. CDO Class I 1992-09-22
K922433 VISTA THYROXINE (T-4) ASSAY -- MODIFICATION Syva Co. KLI Class II 1992-09-18
K923526 OLYMPUS CREATININE REAGENT Olympus Corp. CGX Class II 1992-09-18
K923412 OLYMPUS LACTATE DEHYDROGENASE REAGENT Olympus Corp. CFJ Class II 1992-09-18
K923623 IL TEST ALT, PN 35311 Instrumentation Laboratory CO CKA Class I 1992-09-17
K923286 STRATUS FOLATE FLUOROMETRIC ENZYME-LINKED ASSAY Baxter Diagnostics, Inc. CGN Class II 1992-09-17
K923034 MILES URINE CALCIUM METHOD Heraeus Kulzer, Inc. CIC Class II 1992-09-15
K922888 ONE TOUCH IIB BLOOD GLUCOSE METER Lifescan, Inc. CGA Class II 1992-09-15
K923030 ANI BIOCARD HCG TEST Ani OY JHI Class II 1992-09-15
K923060 IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY Becton Dickinson Advanced Diagnostics JJE Class I 1992-09-15
K923040 MILES URINE GLUCOSE METHOD Heraeus Kulzer, Inc. CFR Class II 1992-09-15
K923322 TRACE ALBUMIN-MR REAGENT Trace Scientific , Ltd. CIX Class II 1992-09-11
K922388 WATERS(TM) LC MODULE I FOR CLINICAL USE Millipore Corp. LDM Class I 1992-09-11
K922953 SYSTEMATE CALCIUM TEST TECHNICON RA 1000 Em Diagnostic Systems, Inc. CIL Class II 1992-09-09
K922857 SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO Em Diagnostic Systems, Inc. CIT Class II 1992-09-09
K922856 SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 Em Diagnostic Systems, Inc. CIG Class II 1992-09-09
K923083 TOTAL BILIRUBIN CATALOG NO. 65407 Em Diagnostic Systems, Inc. CIG Class II 1992-09-09
K923036 URINE CHLORIDE Heraeus Kulzer, Inc. CHJ Class II 1992-09-09
K922698 DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR E.I. Dupont DE Nemours & Co., Inc. JIS Class II 1992-09-09
K923677 AMYLASE TEST Em Diagnostic Systems, Inc. JFJ Class II 1992-09-09
K923203 SYSTEMATE CREATININE TEST Em Diagnostic Systems, Inc. CGX Class II 1992-09-09
K923128 KING DIAGNOSTICS CHOLESTEROL REAGENT King Diagnostics, Inc. CHH Class I 1992-09-09
K923123 HCG PREGNANCY ONE STEP TEST STRIP Tcpi, Inc. JHI Class II 1992-09-09
K923267 SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 Em Diagnostic Systems, Inc. CEK Class II 1992-09-09
K923091 KING DIAGNOSTICS GAMMA GT REAGENT King Diagnostics, Inc. JPZ Class I 1992-09-09
K922701 DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD E.I. Dupont DE Nemours & Co., Inc. JLW Class II 1992-09-09
K923035 MILES URINE UREA NITROGEN METHOD Heraeus Kulzer, Inc. CDQ Class II 1992-09-09
K921949 COTUBE PTH IRMA Bio-Rad CEW Class II 1992-09-02
K922081 LABOTECH AUTOMATED MICROTITER ANALYZER Innovative Medical Systems, Inc. JJQ Class I 1992-09-02
K920291 MONI-TROL-L AND MONI-TROL-XL Medical Analysis Systems, Inc. JJY Class I 1992-09-02
K922170 AMERLITE PROLACTIN-30 ASSAY Eastman Kodak Company CFT Class I 1992-09-02
K923015 TOTAL T3 CHEMILUMINESCENCE ASSAY Nichols Institute Diagnostics CDP Class II 1992-09-02
K923090 SAF-T HOLDER MULTI SAMPLE LUER ADAPTER W/ BLOOD Ryan Medical, Inc. JKA Class II 1992-09-01
K922922 ABL50 BLOOD GAS SYSTEM Radiometer America, Inc. CHL Class II 1992-08-28
K923569 PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT Baxter Diagnostics, Inc. JMO Class I 1992-08-26
K923038 MILES POTASSIUM METHOD Heraeus Kulzer, Inc. CEM Class II 1992-08-24
K923039 MILES URINE CREATININE METHOD Heraeus Kulzer, Inc. CGX Class II 1992-08-24
K922680 DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT E.I. Dupont DE Nemours & Co., Inc. JJE Class I 1992-08-20
K922700 DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. E.I. Dupont DE Nemours & Co., Inc. JHY Class II 1992-08-20
K922273 ARRAY(R) 360 Beckman Instruments, Inc. JQX Class I 1992-08-19
K923608 OLYMPUS DIRECT BILIRUBIN REAGENT Olympus Corp. CIG Class II 1992-08-18
K922964 KING DIAGNOSTIC TRIGLYCERIDES REAGENT King Diagnostics, Inc. CDT Class I 1992-08-18
K921825 QUICK-CHECK II REAGENT STRIP Diagnostic Solutions, Inc. CGA Class II 1992-08-18
K923564 OLYMPUS INORGANIC PHOSPHORUS REAGENT Olympus Corp. CEO Class I 1992-08-18
K923411 OLYMPUS MAGNESIUM REAGENT Olympus Corp. JGJ Class I 1992-08-18
K922770 UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 Leica, Inc. MQM Class I 1992-08-18
K922053 REP SPE PLUS (PONCEAU S) SYSTEM Helena Laboratories CEF Class I 1992-08-18
K922327 DENLEY WELLPREP 2 SAMPLE PROCESSOR Denley Instruments, Inc. JQW Class I 1992-08-12
K922995 LIPID CONTROLS Creative Laboratory Products, Inc. JJX Class I 1992-08-12
K923266 NOVA TOTAL PROTEIN MODULE Nova Biomedical Corp. CEK Class II 1992-08-12
K922696 DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO E.I. Dupont DE Nemours & Co., Inc. JIS Class II 1992-08-12
K922445 VACU-PRO Concord/Portex JKA Class II 1992-08-12
K922183 WELLPREP 2000 SAMPLE PROCESSOR Denley Instruments, Inc. JQW Class I 1992-08-11

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