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Immunology

3,537 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ELM ALLERGEN DISC (K863973)Immuno Nuclear Corp.1986-12-01
ABBOTT B2-MICROGLOBULIN RIA (K864130)Abbott Laboratories1986-11-12
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- (K863858)Hybritech, Inc.1986-11-03
THE FIAX 5000 FLUOROMETER (K863434)Whittaker Bioproducts, Inc.1986-10-29
IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC (K863844)Immuno Nuclear Corp.1986-10-29
ENZYMUN-TEST(R) IGE (K863822)Boehringer Mannheim Corp.1986-10-29
ANTI-DNA MICROASSAY (K863717)Diamedix Corp.1986-10-24
ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT (K862969)Biohytech International, Inc.1986-10-24
MYOLEX (K863730)Orion Corp.1986-10-15
C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS (K863628)Technicon Instruments Corp.1986-10-15
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY (K863345)Hybritech, Inc.1986-10-08
READS RF TEST KIT FOR IGM RHEUMATOID FACTOR (K863238)Biostar Medical Products, Inc.1986-10-08
PHADEBAS RAST/PHADEZYM RAST ALLERTUBE (K863036)Pharmacia, Inc.1986-10-03
QUANTIMUNE(R) FERRITIN IRMA (K863487)Bio-Rad1986-10-01
IMMUNO BIOTECH MUGWART ALLERGEN DISC (K863123)Immuno Nuclear Corp.1986-10-01
ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR (K863329)E.I. Dupont DE Nemours & Co., Inc.1986-09-26
ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST (K863328)E.I. Dupont DE Nemours & Co., Inc.1986-09-26
MICROALBUMINURIA ASSAY (K862671)Orion Corp.1986-09-18
PRECIMAT (R) IGA, G, M (K863352)Boehringer Mannheim Corp.1986-09-17
PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA (K863355)Pharmacia, Inc.1986-09-17
VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY (K862901)Ventrex Laboratories, Inc.1986-09-16
MEADOW FESCUE ALLERGEN DISC (K863098)Immuno Nuclear Corp.1986-09-15
125-I TSH RECEPTOR ANTIBODY KIT (K863006)Cronus1986-09-08
TINA-QUANT(R) IGM (K862762)Boehringer Mannheim Corp.1986-09-08
TINA-QUANT(R) IGA (K862763)Boehringer Mannheim Corp.1986-09-04
CYTOTECH CIC ENZYME IMMUNOASSAY (K862649)Cytotech, Inc.1986-09-04
TINA-QUANT(R) IGG (K862764)Boehringer Mannheim Corp.1986-09-03
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT (K855046)Abbott Laboratories1986-08-27
TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT (K854944)Abbott Laboratories1986-08-27
PHASE II FERRITIN RADIOIMMUNOASSAY KIT (K862960)Medical & Scientific Designs, Inc.1986-08-27
DAKO ITA SYSTEM (K861059)Dako Corp.1986-08-25
DAKO ITA, IMMUNOGLOBULIN M (IGM) (K862184)Dako Corp.1986-08-19
DAKO ITA, IMMUNOGLOBULIN A (IGA) (K862183)Dako Corp.1986-08-19
SERATEST ENA [SS-B] KIT (K862700)Hemagen Diagnostics, Inc.1986-08-19
MAPLE ALLERGEN DISC (K862266)Immuno Nuclear Corp.1986-08-19
COTTONWOOD ALLERGEN DISC (K862265)Immuno Nuclear Corp.1986-08-15
ORCHARD GRASS ALLERGEN DISC (K862939)Immuno Nuclear Corp.1986-08-15
RUSSIAN THISTLE ALLERGEN DISC (K862176)Immuno Nuclear Corp.1986-08-15
CAPPEL DIAGNOSTICS ANA KIT (K862821)Cappel Diagnostics, Inc.1986-08-15
JUNE GRASS ALLERGEN DISC (K862938)Immuno Nuclear Corp.1986-08-15
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM (K862674)Hybritech, Inc.1986-08-15
TIMOTHY ALLERGEN DISC (K862174)Immuno Nuclear Corp.1986-08-06
KALLESTAD SM/RNP TEST REAGENT (K862313)Kallestad Laboratories, Inc.1986-08-06
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN (K860679)Orion Corp.1986-08-04
KALLESTAD SSA/SSB ENA TEST REAGENTS (K862710)Kallestad Laboratories, Inc.1986-07-29
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM (K861773)Zygotek Systems, Inc.1986-07-07
MONO-LATEX (TM) SLIDE TEST (K862008)Armkel, LLC1986-07-03
PERENNIAL RYE ALLERGEN DISC (K862173)Immuno Nuclear Corp.1986-07-03
ENGLISH PLAINTAIN ALLERGEN DISC (K862264)Immuno Nuclear Corp.1986-07-03
AMPLIFIED ELISA IGE KIT (K862368)Allertec, Inc.1986-07-03
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT (K861499)Biostar Medical Products, Inc.1986-06-20
WHITE OAK ALLERGEN DISC (K862175)Immuno Nuclear Corp.1986-06-20
IMMPULSE FERRITIN ASSAY REAGENT (K862014)Sclavo, Inc.1986-06-19
AUTOFLUOR V (K861978)Technia Diagnostics , Ltd.1986-06-10
DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR (K860549)E.I. Dupont DE Nemours & Co., Inc.1986-06-10
DU PONT C-REACTIVE PROTEIN (CRP) ASSAY (K860550)E.I. Dupont DE Nemours & Co., Inc.1986-06-10
IMMUNOMEDICS SERUM ELISA TEST SYSTEM (K861362)Immunomedics, Inc.1986-06-06
SHORT RAGWEED ALLERGEN DISC (K854756)Immuno Nuclear Corp.1986-05-15
SM-RNP AUTOANTIBODY TEST SYSTEM (K860428)Immuno Concepts, Inc.1986-05-15
MONOSTAR SYSTEM: IM LATEX TEST (K861452)U.S. Health Resources Corp.1986-05-13
QUIDEL ALLERGY SCREEN (K861171)Quidel Corp.1986-04-25
IAP PLATE TEST (K861336)Scientific Sales Intl., Inc.1986-04-25
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST (K861167)Atlantic Antibodies1986-04-25
PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS (K861184)Pharmacia, Inc.1986-04-25
PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5 (K854865)Pharmacia, Inc.1986-04-22
THABEST-IGE (K855053)Visual Diagnostics, Inc.1986-04-22
FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY (K860027)Alerchek, Inc.1986-04-22
SERATEST RF (HEMAGGLUTINATION) KIT (K855221)Hemagen Diagnostics, Inc.1986-04-22
GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS (K861016)Gamma Biologicals, Inc.1986-04-18
BEHRING NEPHELOMETER SYSTEM (K860894)Behring Diagnostics, Inc.1986-04-15
TOTAL IGE-IRMA RIA KIT (K860032)Diagnostic Products Corp.1986-04-11
EIA MONOCLONAL TOTAL IGE KIT (K860033)Diagnostic Products Corp.1986-04-07
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM (K860138)Sigma Diagnostics, Inc.1986-03-28
ENZYMUN-TEST FERRITIN (K860137)Boehringer Mannheim Corp.1986-03-28
ALLEGRO IGE ENZYME IMMUNOASSAY SYSTEM (K860851)Nichols Institute Diagnostics1986-03-28
SS-A/SS-B AUTOANTIBODY TEST SYSTEM (K860644)Immuno Concepts, Inc.1986-03-28
QUANTIMETRIC PLUS IGM REAGENT KIT (K855010)Kallestad Laboratories, Inc.1986-02-28
CPR SLIDE EIKEN (K854819)Syn-Kit, Inc.1986-02-26
QUANTIMETRIC PLUS LAMBDA REAGENT KIT (K855007)Kallestad Laboratories, Inc.1986-02-26
QUANTIMETRIC PLUS C4 REAGENT KIT (K855012)Kallestad Laboratories, Inc.1986-02-26
QUANTIMETRIC PLUS KAPPA REAGENT KIT (K855008)Kallestad Laboratories, Inc.1986-02-26
QUANTIMETRIC PLUS IGA REAGENT KIT (K855009)Kallestad Laboratories, Inc.1986-02-26
AFT-HEP SYSTEM (K860183)Behring Diagnostics, Inc.1986-02-26
LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) (K855057)Behring Diagnostics, Inc.1986-02-26
QUANTIMETRIC PLUS C3 REAGENT KIT (K855011)Kallestad Laboratories, Inc.1986-02-26
COATEST PLASMINOGEN (K854572)Kabivitrum, Inc.1986-02-26
QUANTIMETRIC PLUS SUPPORT PACK (K855013)Kallestad Laboratories, Inc.1986-02-26
TDX TRANSFERRIN DIAGNOSTIC KIT (K854416)Abbott Laboratories1986-02-21
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES (K854939)Pharmacia, Inc.1986-02-13
DIESSE RF TEST KIT (K854222)Marvic Interpharma, Inc.1986-02-06
ASSERACHROM FPA KIT (K854384)American Bioproducts Co.1986-02-04
TDX C-REACTIVE PROTEIN (K854542)Abbott Laboratories1986-01-24
APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (K854875)Photec Diagnostics, Inc.1986-01-24
ICS PAB PREALBUMIN REAGENT TEST KIT (K854811)Beckman Instruments, Inc.1986-01-24
RA 80 EIKEN (K854820)Syn-Kit, Inc.1986-01-17
FANA 60 (K854314)American Bio-Reagents, Inc.1985-12-16
BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT (K853697)Biostar Medical Products, Inc.1985-12-16
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT (K854483)Kallestad Laboratories, Inc.1985-12-11
72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 (K850683)Kent Laboratories, Inc.1985-11-27
72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL (K850682)Kent Laboratories, Inc.1985-11-25
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