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Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
65
Latest Decision
1986-10-29

Clearances · page 86 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K864119 URIC ACID TEST U. S. Diagnostics, Inc. KNK Class I 1986-10-29
K863648 SERACON CT REFERENCE Bhp Diagnostix, Inc. JJY Class I 1986-10-29
K863478 CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 Em Diagnostic Systems, Inc. JGQ Class II 1986-10-29
K863718 EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 Em Diagnostic Systems, Inc. CEO Class I 1986-10-29
K861882 IMMUNOCHEMICAL ASSAY APOLIPOPROTEIN B Orion Corp. MSJ Class I 1986-10-29
K863491 BLOOD SPECIMEN COLLECTION DEVICES Medelec Intl. Corp. JKA Class II 1986-10-24
K863617 ION 2/4 FLOW CELL CLEANER (PRODUCT #88656) Hi Chem, Inc. JGS Class II 1986-10-24
K863976 OCEAN SCIENTIFIC VACUTEST Ocean Scientific, Inc. JKA Class II 1986-10-24
K863265 DIRECT BILIRUBIN PROCEDURE Data Medical Associates, Inc. CIG Class II 1986-10-24
K863502 SOLUTION B- NA 50MEQ/L, K 40 MEQ/L Reagent Laboratory, Inc. JIX Class II 1986-10-21
K863624 ULTRAWASH II Dynatech Laboratories, Inc. JQW Class I 1986-10-21
K863623 ULTRAWASH I Dynatech Laboratories, Inc. JQW Class I 1986-10-21
K863531 IQ IMMUNOCHEMISTRY SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic JJE Class I 1986-10-20
K862561 TECHNICON RA-XT SYSTEM WITH ANALYTES Technicon Instruments Corp. JJC Class I 1986-10-20
K863678 FOLLICLE STIMULATING HORMONE IMMUNOASSAY SYSTEM Nichols Institute Diagnostics CGJ Class I 1986-10-16
K863585 CHLORIDE PROCEDURE Data Medical Associates, Inc. CHJ Class II 1986-10-16
K863679 ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM Nichols Institute Diagnostics CEP Class I 1986-10-16
K863566 GSC 1000 Genetic Systems Corp. JJQ Class I 1986-10-16
K863851 ACID PHOSPHATASE (ACP) REAGENT Sigma Diagnostics, Inc. CKB Class II 1986-10-16
K862233 CIBA CORNING PRISMA T4 LIPIA (LIPOSOME) Ciba Corning Diagnostics Corp. KLI Class II 1986-10-14
K863121 PEAK OVULATION PREDICTOR Micron Technology, Inc. NGE Class I 1986-10-14
K863745 ABNORMAL SPINAL FLUID CONTROL Ciba Corning Diagnostics Corp. JJY Class I 1986-10-07
K862447 PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. KHQ Class II 1986-10-07
K863586 GAMMA GLUTAMYL TRANSFERASE PROCEDURE Data Medical Associates, Inc. JPZ Class I 1986-10-03
K863622 TDX(R) AMYLASE II Abbott Laboratories JFJ Class II 1986-10-03
K863587 CREATINE PHOSPHOKINASE(CK) PROCEDURE Data Medical Associates, Inc. CGS Class II 1986-10-03
K861263 BEHRING RAPIMAT II Behring Diagnostics, Inc. JJQ Class I 1986-10-03
K863255 LACTATE DEHYDROGENASE(LD) PROCEDURE Data Medical Associates, Inc. CFJ Class II 1986-10-03
K861255 BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS Behring Diagnostics, Inc. JIL Class II 1986-10-03
K863261 CREATININE PROCEDURE Data Medical Associates, Inc. CGX Class II 1986-10-02
K863425 AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 American Research Products Co. CDW Class II 1986-10-01
K863588 AMYLASE PROCEDURE Data Medical Associates, Inc. JFJ Class II 1986-09-29
K863240 PROLACTIN RIABEAD II DIAGNOSTIC KIT Abbott Laboratories CFT Class I 1986-09-29
K862733 AMYLASE SR LIQUID STABLE REAGENT SET Medical Analysis Systems, Inc. JFJ Class II 1986-09-29
K863287 URIC ACID (URICASE) METHOD-II Catachem, Inc. JHC Class I 1986-09-29
K863486 POTASSIUM TEST Sclavo, Inc. CEJ Class II 1986-09-29
K863333 AVL ISE-TROL ELECTROLYTE CONTROL Avl Scientific Corp. JJR Class I 1986-09-29
K863438 NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER Nova Biomedical Corp. JJP Class I 1986-09-29
K863198 PREGNASLIDE Armkel, LLC JHJ Class II 1986-09-29
K863544 EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95 Em Diagnostic Systems, Inc. KHS Class II 1986-09-29
K862148 OLYMPUS AU 5000 FLAME PHOTOMETER MODULE Olympus Corp. JJO Class I 1986-09-29
K863489 PARAMAX ELECTROLYTE CALIBRATOR American Dade JIX Class II 1986-09-29
K863252 CHOLESTEROL PROCEDURE Data Medical Associates, Inc. CHH Class I 1986-09-29
K861244 HDL/CHOLESTEROL TEST SYSTEM Chrometrics Laboratories, Inc. LBS Class I 1986-09-29
K863258 TOTAL PROTEIN PROCEDURE Data Medical Associates, Inc. CEK Class II 1986-09-29
K863268 ALKALINE PHOSPHATASE PROCEDURE Data Medical Associates, Inc. CJE Class II 1986-09-29
K863256 CALCIUM PROCEDURE Data Medical Associates, Inc. CIC Class II 1986-09-26
K863301 DEMAND TOTAL PROTEIN Cooper Biomedical, Inc. CEK Class II 1986-09-26
K863075 TRIGLYCERIDES-E J. D. Assoc. CDT Class I 1986-09-26
K862498 ALKALINE PHOSPHATASE TEST King Diagnostics, Inc. CJE Class II 1986-09-26
K863259 GLUCOSE HK PROCEDURE Data Medical Associates, Inc. CFR Class II 1986-09-26
K863251 URIC ACID PROCEDURE Data Medical Associates, Inc. KNK Class I 1986-09-26
K863254 TRIGLYCERIDE (TRINDER) PROCEDURE Data Medical Associates, Inc. CDT Class I 1986-09-26
K863257 AST/GOT PROCEDURE Data Medical Associates, Inc. CIT Class II 1986-09-26
K863422 DELFIA(TM) CORTISOL KIT Lkb Instruments, Inc. JFT Class II 1986-09-26
K863057 BILIRUBIN TOTAL DIRECT J. D. Assoc. CIG Class II 1986-09-26
K863059 CALCIOMETER J. D. Assoc. CIA Class II 1986-09-26
K862312 ENZLIPASE, ENZYMATIC LIPASE KIT Nuclear Diagnostics, Inc. CHI Class I 1986-09-26
K863620 RAICHEM(TM) CHLORIDE REAGENT Reagents Applications, Inc. CHJ Class II 1986-09-26
K863477 EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 Em Diagnostic Systems, Inc. CFJ Class II 1986-09-26
K863095 ACE II (TRI-LEVEL) Medical Analysis Systems, Inc. JIX Class II 1986-09-26
K862204 RSL (125I) ALDOSTERONE KIT Radioassay Systems Laboratories, Inc. CJM Class II 1986-09-25
K863188 HPL RIA KIT Biotecx Laboratories, Inc. JMX Class I 1986-09-25
K862968 FREE T3 RADIOIMMUNOASSAY KIT Bioclinical Group KHQ Class II 1986-09-25
K863062 CHOLESTEROL-E (TOTAL) J. D. Assoc. CHH Class I 1986-09-25
K863545 EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 Em Diagnostic Systems, Inc. CFJ Class II 1986-09-25
K863088 ABBOTT SPECTRUM PHOSPHORUS REAGENT Abbott Laboratories CEO Class I 1986-09-25
K862336 PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. CGR Class II 1986-09-25
K863262 TOTAL BILIRUBIN PROCEDURE Data Medical Associates, Inc. CIG Class II 1986-09-17
K863226 ALBUMIN (BCP) Sigma Diagnostics, Inc. CJW Class II 1986-09-17
K863426 AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241 American Research Products Co. JMO Class I 1986-09-16
K863003 EMDS(TM) CALCIUM TESTPACKS, #67687/95 Em Diagnostic Systems, Inc. CIC Class II 1986-09-16
K863004 EMDS(TM) ALBUMIN TESTPACKS, #67652/95 Em Diagnostic Systems, Inc. CJW Class II 1986-09-16
K863253 ALT/GPT PROCEDURE Data Medical Associates, Inc. CKA Class I 1986-09-16
K862813 FSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT Serono Diagnostics, Inc. CGJ Class I 1986-09-16
K861420 QUANTIMETRIX DRUG FREE HUMAN URINE CONTROL Quantimetrix Corp. JJY Class I 1986-09-16
K861354 RIGHT-DAY OVULATION HOME TEST Leeco Diagnostics, Inc. CEP Class I 1986-09-16
K863099 ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT Abbott Laboratories JJK Class I 1986-09-16
K861449 VACUUM BLOOD COLLECTING SYSTEM (NEO-TUBE) Exel Intl. GIM Class II 1986-09-16
K863199 CARDS(TM) HCG-URINE Pacific Biotech, Inc. JHI Class II 1986-09-15
K863127 TESTPACK ACUTE HCG URINGE CONTROLS Abbott Laboratories JJW Class I 1986-09-15
K862963 THERAPEUTIC DRUG MONITORING CONTROL SET American Monitor Corp. JJY Class I 1986-09-15
K862999 ULTRASCAN CLINICAL ANALYZER Specialty Medical Industries, Inc. JJQ Class I 1986-09-15
K863126 TESTPACK ACUTE HCG SERUM CONTROLS Abbott Laboratories JJX Class I 1986-09-15
K863032 ABBOTT TESTPACK (TM) HCG SERUM Abbott Laboratories JHI Class II 1986-09-15
K862908 AKERSCAN COLORIMETRIC ANALYZER Akers Medical Technologies JJQ Class I 1986-09-15
K863263 ALBUMIN PROCEDURE Data Medical Associates, Inc. CIX Class II 1986-09-15
K863267 MAGNESIUM PROCEDURE Data Medical Associates, Inc. CFA Class I 1986-09-11
K863050 ALBUMETER J. D. Assoc. CIX Class II 1986-09-11
K863064 CHOLESTEROL-E (FREE) J. D. Assoc. CHH Class I 1986-09-11
K863070 FAST MUCOPROTEINS J. D. Assoc. JQN Class I 1986-09-11
K863264 INORGANIC PHOSPHORUS PROCEDURE Data Medical Associates, Inc. CEO Class I 1986-09-11
K863266 IRON PROCEDURE Data Medical Associates, Inc. JIY Class I 1986-09-11
K863071 PHOSPHOLIPIDS-E J. D. Assoc. CEQ Class I 1986-09-09
K863061 CLOROFAST J. D. Assoc. CHJ Class II 1986-09-09
K863072 FOSFOROMETER J. D. Assoc. CEO Class I 1986-09-09
K863073 TOTAL LIPIDS J. D. Assoc. CFD Class I 1986-09-09
K863052 ALPHA AMYLASE J. D. Assoc. CJA Class II 1986-09-09
K863051 ALP S.C.E. J. D. Assoc. CJE Class II 1986-09-09
K863260 BLOOD UREA NITROGEN(BUN) PROCEDURE Data Medical Associates, Inc. CDQ Class II 1986-09-09

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