Atlas FDA

Clinical Chemistry

13,051 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
LKB 2164 MACRO-SPIN R CENTRIFUGE (K831942)Lkb Instruments, Inc.1983-07-29
LKB 2160 MIDISPIN CENTRIFUGE (K831947)Lkb Instruments, Inc.1983-07-29
LKB 2161 MIDISPIN R CENTRIFUGE (K831948)Lkb Instruments, Inc.1983-07-29
DIA STRIPS SYSTEM (K831623)California Immuno Diagnostic, Inc.1983-07-28
MODEL 947 VIDEO BLOOD GAS SYS (K831379)Avl Scientific Corp.1983-07-28
PRO QUANTUM (K831249)Abbott Laboratories1983-07-28
MODEL DMS 100 ULTRAVIOLET-VISIBLE SPEC (K831866)Varian Assoc., Inc.1983-07-28
HATCH KIT (K831855)Radioassay Systems Laboratories, Inc.1983-07-28
TRIGLYCERIDES REAGENT SET (K831858)Stanbio Laboratory1983-07-22
CHOLESTEROL-ENZYMATIC REAGENT SET (K831863)Stanbio Laboratory1983-07-22
URIC-ACID TEST ENZYMATIC COLORIMETRIC (K831864)Stanbio Laboratory1983-07-22
RENAK (K831694)Hoffmann-La Roche, Inc.1983-07-19
BETA SCAN NORMAL CONTROL SOLUTION (K831523)Orange Medical Instruments, Inc.1983-07-19
MULTICHEM ENZYMATIC CHOLESTEROL SYS (K831700)Simmler, Inc.1983-07-19
GLUCOSE REAGENT B6360-11 (K831634)American Scientific Products1983-07-19
HCG ACCU-STICK (K831604)Btc Diagnostics, Inc.1983-07-19
ASTRA SYSTEMS ENZYME MODULE LD-P (K832048)Beckman Instruments, Inc.1983-07-19
QUANTIMUNE HFSH RIA HUMAN FOLLICLE- (K831742)Bio-Rad1983-07-18
GILCHEM TOTAL BILIRUBIN REAGENT (K831843)Gilford Diagnostics1983-07-18
SPINAL FLUID TOTAL PROTEIN CONTROL (K831527)Quantimetrix Corp.1983-07-18
MONOJET SPS BLOOD COLLECTION TUBE (K831719)Sherwood Medical Co.1983-07-18
QEA SODIUM/POTASSIUM ANALYZER (K832036)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-07-18
CERTAIN HB CO-OXIMETER CONTROL (K832028)Corning Medical & Scientific1983-07-18
ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY (K831826)Damon Corp.1983-07-18
WAKO CHOLESTEROL CII (K831687)Wako Chemicals USA, Inc.1983-07-18
DIRECT BILIRUBIN REAGENT (K831844)Gilford Diagnostics1983-07-18
WAKO R-GTP C-TEST (K831639)Wako Chemicals USA, Inc.1983-07-18
MSI-NAK-50 TEST KIT (K831300)Medical Specialties, Inc.1983-07-18
ELECTROPHORESIS CONTROLS-3 IN 1 (K831263)Corning Medical & Scientific1983-07-07
UREA NITROGEN-BUN-REAGENTS B6360-12 (K831625)American Scientific Products1983-07-07
UREA NITROGEN-BUN-REAGENTS B6370-11A (K831626)American Scientific Products1983-07-07
AMYLAST-D TEST (K831561)Sclavo, Inc.1983-07-07
GLUCOSE OXIDASE/PEROXIDASE TEST (K831411)King Diagnostics, Inc.1983-07-06
CREATININE REAGENTS B6360-10 (K831627)American Scientific Products1983-07-06
GLUCOSE REAGENT KITS-B6370-10A (K831624)American Scientific Products1983-07-06
CREATININE REAGENTS B6370-13 (K831628)American Scientific Products1983-07-06
GLUCOSE HEXOKINASE DIAG. KIT (K831560)Sclavo, Inc.1983-07-06
ROTOR (K831571)American Scientific Products1983-06-30
SPECIFIC GRAVITY INSTRUMENT (K831213)Iris1983-06-30
MAGIC T4 125I RADIOIMMUNOASSAY (K831533)Corning Medical & Scientific1983-06-30
AMYLASE REAGENT #88129 (K831295)Hi Chem, Inc.1983-06-30
REAGENT CUPS (K831569)American Scientific Products1983-06-30
ISO-SEP SYSTEM (K831434)Berwick Medical Products, Inc.1983-06-30
E.P.T. PLUS TM (K831535)Warner-Lambert Co.1983-06-30
EVENT-TEST SLIDE (K831383)Icl Scientific1983-06-22
PTH MR (K831470)Ramco Laboratories, Inc.1983-06-22
B HCG-CHECK (K831468)Diagnostic Technology, Inc.1983-06-22
PARAMAX ALKALINE PHOSPHATASE REAGENT- (K831480)American Dade1983-06-22
AUTO CAROUSE/WASH SOLUTION CONCENTRATE (K831518)Syva Co.1983-06-22
PARAMAX CREATINE KINASE REAGENT (K831537)American Dade1983-06-22
BLOOD GAS & FLAME PHOTOMETER INSTRU- (K831075)United Diagnostics, Inc.1983-06-22
HCG-CHECK (K831466)Diagnostic Technology, Inc.1983-06-22
URI-TEST 3, INLAB REAGENT STRIPS-URINAL (K831498)Laprol Scientific, Inc.1983-06-22
YELLOW IRIS TM (K830220)Intl. Remote Imaging Systems1983-06-17
GLUCOSE 3, INLAB REAGENT STRIPS-URINALY (K831499)Laprol Scientific, Inc.1983-06-17
DEMAND ANALYZER SYSTEM (K831477)Worthington Diagnostic Systems1983-06-17
PARAMAX AMALINE REAGENT (K831536)American Dade1983-06-17
PREFILLED IEC COLUMNS (K831289)Berwick Medical Products, Inc.1983-06-16
PH 6.838 REF. BUFFER (K831019)Fisher Scientific Co., LLC1983-06-16
DAC-CEL PTH KIT RD51 (K831069)Wellcome Diagnostics1983-06-16
LACTIC DEHYDROGENASE REAGENT SET (K831415)Sterling Biochemical, Inc.1983-06-16
ELECTROLYTE PO2 FOR OXYGEN ELECTRODES (K831024)Fisher Scientific Co., LLC1983-06-16
CALIBRATING SOLUTION FOR ABL-1 & 2 (K831021)Fisher Scientific Co., LLC1983-06-16
RAICHEM LDH-P REAGENT W/SEPARATE START- (K831419)Reagents Applications, Inc.1983-06-16
COLORIMETRIC BUN (K831414)Bio-Analytics Laboratories, Inc.1983-06-16
CALIBRATING SOLUTION FOR ABL-1 & 2 (K831018)Fisher Scientific Co., LLC1983-06-16
ALBUMIN REAGENT (BCG (K831585)Reagents Applications, Inc.1983-06-16
ELECTROLYLE CARBON DIOXIDE ELECTRODES (K831025)Fisher Scientific Co., LLC1983-06-16
REFERENCE BUFFER PH 7.382 (K831023)Fisher Scientific Co., LLC1983-06-15
URINE SCREENING KIT (K830824)Syn-Kit, Inc.1983-06-12
LINEAR ENZMATIC URIC ACID SYSTEM (K831398)Simmler, Inc.1983-06-08
DIAGNOSTICS PO 2 ELECTROLYTE (K831013)Fisher Scientific Co., LLC1983-06-08
DATA-ZYME ALKALINE PHOSPHATASE PROCED (K831360)Data Medical Associates, Inc.1983-06-08
RIANEN PROLACTIN 125I KIT (K831345)New England Nuclear1983-06-08
NEO-PREGNOSTICON DUOCLON TUBE TEST (K831339)Organon, Inc.1983-06-08
DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON (K831012)Fisher Scientific Co., LLC1983-06-08
PBI BHCG RIA KIT (K831302)Pacific Biotech, Inc.1983-06-08
LIPOSOL (K830472)Quest Medical, Inc.1983-06-08
ASTRA SYSTEMS ENZYME MODULE (K831353)Beckman Instruments, Inc.1983-06-08
BHCG RIA KIT (K831264)Micromedic Systems1983-06-08
BETA-PREG (K831361)Catheter Technology Corp.1983-06-02
QST TM SAMPLE PROCESSOR (K831273)Syva Co.1983-06-02
TESTCORP PREG (K831366)Catheter Technology Corp.1983-06-02
ARIA II I-HCG (K830997)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-06-02
RIAGEN B-HCG RIA KIT (K831221)Biogenex Laboratories1983-06-02
DUOCLON SLIDE TEST (K831109)Organon, Inc.1983-06-02
BETA-QUIK-15 RIA KIT (K831223)Pacific Biotech, Inc.1983-06-02
COAT-A-COUNT NO-EXTRACTION TESTOSTERONE (K831342)Diagnostic Products Corp.1983-06-02
B-CLONE HCG ASSAY (K831155)Monoclonal Antibodies, Inc.1983-06-02
COMPUR EASY TOUCH CHEMISTRY ANALYZER- (K831227)Worthington Diagnostic Systems1983-06-02
PREGNA-CERT, SLIDE PREGNANCY TEST (K831180)Diagnostic Specialties1983-05-27
COAT-A-COUNT NO-EXTRACTION ALDOSTERONE (K831178)Diagnostic Products Corp.1983-05-27
EMIT SRD MANUAL CORTISOL ASSAY (K831141)Syva Co.1983-05-27
SERUM UIBC-PTF-600 METHOD (K831202)American Monitor Corp.1983-05-25
AMERLEX FREE T-3 RIA KIT (K830980)Amersham Corp.1983-05-25
SERUM IRON-PTF-600 (K831201)American Monitor Corp.1983-05-25
DIAGNOSTICS PH ELECTRODE CLEANING SOLUT (K831015)Fisher Scientific Co., LLC1983-05-25
COAT-A-COUNT NEONATAL T4 KIT RIA KIT (K831107)Diagnostic Products Corp.1983-05-18
HOME PREGNANCY TEST KIT (K831108)Quidel Corp.1983-05-18
HOME PREGNANCY TEST KIT HPK #1 (K831051)Quidel Corp.1983-05-18
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