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Immunology

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

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RecordFirmDate
TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM (K842470)Miles Laboratories, Inc.1984-08-28
ALLERGENETICS ALLER-SPECIFIC IGE SERUM (K842969)Allergenetics1984-08-28
FIAX TOTAL IGE TEST KIT (K842749)Intl. Diagnostic Technology1984-08-28
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG (K842468)Miles Laboratories, Inc.1984-08-28
ADP NDNA IFA TEST (K842707)Apple Diagnostic Products1984-08-21
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN (K842328)Bartels Immunodiagnostic Supplies, Inc.1984-08-03
AMER. HISTO-ID SYS PRIMARY IGM S7920-31 (K842327)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
AMER. HISTO-ID SYS PRIMARY IGG S7920-11 (K842329)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
AMER. HISTO-ID SYS PRIMARY KIT (K842326)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
AMER. HISTO-ID SYS PRIMARY IGA 2720-21 (K842330)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
LEAP LE TEST KIT (K842484)Cooper Biomedical, Inc.1984-07-11
FIAX TRANSFERRIN TEST KIT (K842071)Intl. Diagnostic Technology1984-07-11
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT (K841864)Kallestad Laboratories, Inc.1984-07-11
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE (K842457)Pharmacia, Inc.1984-07-02
MELOY AUTOANTIBODY TEST SYS (K842247)Meloy Laboratories, Inc.1984-06-26
ENZYMATIC ACETAMINOPHEN ASSAY (K841930)Diagnostic Chemicals, Ltd. (Usa)1984-06-25
ANA SENSITIVITY/SPECIFICITY CONTROL (K841776)Behring Diagnostics, Inc.1984-06-22
OPTIMATE IGM TEST (K841814)Miles Laboratories, Inc.1984-06-22
OPTIMATE IGG TEST (K841816)Miles Laboratories, Inc.1984-06-22
GMP CIQ ELISA TEST KIT (K833275)Gamma Medical Products, Inc.1984-06-22
ADP ANA IFA TEST (K842183)Apple Diagnostic Products1984-06-22
ALLO-TYPE HUMAN IMMUNOGLOBULIN- (K841114)Genetic Testing Institute1984-06-14
MONO-TEC (K841863)Medilab Corp.1984-06-13
IMMU-TEC (K841862)Medilab Corp.1984-06-13
ORTHO* SERUM ELISA TEST SYSTEM (K833636)Ortho Diagnostic Systems, Inc.1984-06-13
MODIFICATION TO ACS CORONARY GUIDING (K841992)Advanced Cardiovascular Systems, Inc.1984-06-11
ALLERCOAT ALLERGEN DISCS (K842125)Kallestad Laboratories, Inc.1984-06-07
PHARMACIA IGE RIA (K841824)Pharmacia, Inc.1984-06-07
PHADEBAS RAST PHADEZYM RAST ALLERGEN (K841829)Pharmacia, Inc.1984-06-07
MAST LUMINESCENT ALLERGY SYS (K841642)Mast Immunosystems1984-06-07
OPTIMATE IGA TEST (K841815)Miles Laboratories, Inc.1984-06-01
VAST VENTREX RAST ALL (K841651)Ventrex Laboratories, Inc.1984-06-01
TAGO FIFFU-GEN, OROSOMUCOID (K841734)Tago, Inc.1984-06-01
SERUM COMPLEMENT ACTIVITY TEST-SCAT (K841541)Collaborative Research, Inc.1984-06-01
DSL FERRITIN IRMA (K841925)Diagnostic Systems Laboratories, Inc.1984-05-25
TAGO DIFFU-GEN C-REACTIVE PROTEIN (K841265)Tago, Inc.1984-05-22
EXTRACTABLE NUCLEAR ANTIGEN ASSAY (K840221)Zeus Scientific, Inc.1984-05-22
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN (K840830)Ventrex Laboratories, Inc.1984-05-21
PHADEXACT SERUM, TOTAL IGE CONTROLS (K840476)Pharmacia, Inc.1984-05-21
VENTRESCREEN, MULTIPLE ALLERGEN DISCS (K841516)Ventrex Laboratories, Inc.1984-05-11
ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN (K840867)Intl. Diagnostic Technology1984-05-11
RF TEST KIT (K841454)Difco Laboratories, Inc.1984-04-25
VIRGO REAGENTS INDIRECT FLUORSCENT (K841127)Electro-Nucleonics Laboratories, Inc.1984-04-25
B2-MICRO CONTROL (K840601)Pharmacia, Inc.1984-04-20
NCS RA LATEX TEST (K841146)Ncs Diagnostics, Inc.1984-04-20
ANTI-NATIVE DNA ANTIBODY (K834349)Sigma Chemical Co.1984-04-19
PHADEBAS RAST PHADEZYM MIX ALLERG (K840670)Pharmacia, Inc.1984-04-18
PHADEBAS RAST TEST -ALLERGEN DISCS (K840876)Pharmacia, Inc.1984-04-17
LEAP MONO TEST KIT (K840822)Cooper Biomedical, Inc.1984-04-05
SOMAS HUMAN SPINAL FLUID CONTROL (K840974)Somas Medical Industries, Inc.1984-04-05
ANA APPLELISA (K834241)Apple Diagnostic Products1984-04-04
SENSIBEAD EIA IGE KIT (K840674)Terumo Medical Corp.1984-04-04
SERATEST RF LATEX DETERMINATION (K840863)Seragen Diagnostics, Inc.1984-04-04
MAST INHALANT PROFILE (K834526)Mast Immunosystems1984-04-04
RAST ALLERGO SORBENT TEST (K840537)Pharmacia, Inc.1984-04-02
CORNINGS MAGIC FERRITIN RADIOIMMUNO- (K840460)Corning Medical & Scientific1984-03-30
IMMPULSE SYSTEM (K834070)Paragon Diagnostics, Inc.1984-03-23
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE (K840538)Pharmacia, Inc.1984-03-23
CRP SLIDE TEST KIT (K840699)Difco Laboratories, Inc.1984-03-23
CHYMOFAST TEST (K833418)Allergenetics1984-03-12
ALLERCOAT MULTISCREEN DISCS (K840360)Kallestad Laboratories, Inc.1984-03-09
DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO (K840404)Tago, Inc.1984-03-09
NABI CRP-Q.S. TEST (K834584)Intl. Diagnostic, Inc.1984-02-27
NABI RF-Q.S. TEST (K840005)Intl. Diagnostic, Inc.1984-02-13
LIGHT TEST (K834598)Hemogenetics, Inc.1984-02-10
RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN (K840103)Techniclone Intl.1984-02-10
IM-CHECK (K834345)Diagnostic Technology, Inc.1984-02-10
SOPHEIA MP IGM RHEUMATOID FACTOR EIA (K840049)Diagnostic Products Corp.1984-02-10
TOTAL IGE FAST TEST (K834594)Allergenetics1984-02-10
LABELED 125I ANTI-IGE (K833419)Allergenetics1984-02-03
IMMUNO-RA (K834391)Immunostics Co., Inc.1984-02-03
IMMUNO-CRP (K834390)Immunostics Co., Inc.1984-02-03
C3 ANTISERUM CONTROL (K834604)Technicon Instruments Corp.1984-01-24
C4 ANTIGEN ANTIBODY CONTROL (K834605)Technicon Instruments Corp.1984-01-24
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN (K833402)Technicon Instruments Corp.1984-01-24
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS (K834140)Intl. Diagnostic Technology1984-01-20
MAST TOTAL IGE (K833969)Mast Immunosystems1984-01-04
IL TEST IGG IGA & IGM KITS (K833841)Instrumentation Laboratory CO1984-01-04
MAST INHALANT PROFILE (K833885)Mast Immunosystems1984-01-04
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL (K833984)Intl. Diagnostic Technology1984-01-04
NORMAL GOAT SERUM (K833318)Biosan Laboratories, Inc.1984-01-03
POLYSTYRENE MICROTITER WELL IMMUNOSOR (K832345)Diagnostic Reagent Tech.1983-11-25
DIACROM *PLG (K832591)Wellcome Diagnostics1983-11-21
POLYSTYRENE MICROTITER PLATE IMMUNO- (K832344)Diagnostic Reagent Tech.1983-11-21
POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE (K831984)Diagnostic Reagent Tech.1983-11-21
AUTOIMMUNE TEST 1/2/3 SYSTEM (K833119)Atlantic Antibodies1983-11-21
ENZYME ANA TEST SYSTEM (K833148)Immuno Concepts, Inc.1983-11-21
FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (K832262)Gelco Diagnostics, Inc.1983-10-31
GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC (K832258)Gelco Diagnostics, Inc.1983-10-31
FITC GOAT ANTI-HUMAN LAMBA (K832267)Gelco Diagnostics, Inc.1983-10-31
FITC GOAT ANTI-HUMAN KAPPA AFFINITY (K832266)Gelco Diagnostics, Inc.1983-10-31
GOAT ANTI-HUMAN KAPPA AFFINITY (K832260)Gelco Diagnostics, Inc.1983-10-31
FITC GOAT ANTI-HUMAN IGM H CHAIN (K832265)Gelco Diagnostics, Inc.1983-10-31
GOAT ANTI-HUMAN IMMUNOGLOBULINS- (K832256)Gelco Diagnostics, Inc.1983-10-31
FITC GOAT ANTI-HUMAN IGA A CHAIN (K832263)Gelco Diagnostics, Inc.1983-10-31
GOAT ANTI-HUMAN LAMBA (K832270)Gelco Diagnostics, Inc.1983-10-31
GOAT ANTI-HUMAN LAMBA AFFINITY (K832261)Gelco Diagnostics, Inc.1983-10-28
GOAT ANTI-HUMAN IGM H CHAIN (K832259)Gelco Diagnostics, Inc.1983-10-28
GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (K832257)Gelco Diagnostics, Inc.1983-10-28
FITC GOAT ANTI-HUMAN IGG Y CHAIN (K832264)Gelco Diagnostics, Inc.1983-10-28
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