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Immunology

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

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RecordFirmDate
WALNUT ALLERGEN DISC (K874883)Incstar Corp.1988-05-11
DPC'S ALLERGEN-SPECIFIC IGE SYSTEM (K880160)Diagnostic Products Corp.1988-04-21
PHARMACIA B2-MICRO RIA (K880719)Pharmacia, Inc.1988-04-21
NOVA GEL (TM) SCL-70 (K880897)Inova Diagnostics, Inc.1988-04-21
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. (K881138)Baxter Healthcare Corp1988-04-21
IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS (K881675)Dynatech Laboratories, Inc.1988-04-21
INCSTAR'S DANDELION ALLERGEN DISC (K880187)Incstar Corp.1988-04-21
WHITE ASH ALLERGEN DISC (K880567)Incstar Corp.1988-04-21
ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM (K875244)Diagnostic Products Corp.1988-04-21
GOLDENROD ALLERGEN DISC (K875163)Incstar Corp.1988-04-21
QM300 CALIBRATOR D PACK (K881127)Kallestad Diag, A Div. of Erbamont, Inc.1988-04-21
NOVA LITE(TM) ANA PLUS (K881339)Inova Diagnostics, Inc.1988-04-21
MESQUITE ALLERGEN DISC (K880415)Incstar Corp.1988-04-21
N PROTEIN STANDARD PLASMA (HUMAN) (K880356)Behring Diagnostics, Inc.1988-04-07
MONO-PHILE (K881247)Bio Diagnostic Systems, Inc.1988-04-07
IVT CENTRAL ALLERGY SCREEN (K875329)In Vitro Technologies, Inc.1988-04-07
QUIDEL ALLERGY SCREEN (K874717)Quidel Corp.1988-04-06
QM300 ALBUMIN ANTIBODY PACK (K881126)Kallestad Diag, A Div. of Erbamont, Inc.1988-04-06
NOVA GEL(TM) SM/RNP (K881181)Inova Diagnostics, Inc.1988-04-06
SM ANTIBODY TEST KIT (K880254)Lipogen, Inc.1988-04-06
KALLESTAD QM300 CALIBRATOR C PACK (K880729)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-30
WAKO(TM) IGA-HA DIRECT (K880803)Wako Chemicals USA, Inc.1988-03-29
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY (K880547)Ventrex Laboratories, Inc.1988-03-25
NOVA LITE(TM) ANA (K880736)Inova Diagnostics, Inc.1988-03-25
NOVA GEL(TM) SS-A/SS-B (K880896)Inova Diagnostics, Inc.1988-03-25
WAKO(TM) IGM-HA DIRECT (K880828)Wako Chemicals USA, Inc.1988-03-25
KALLESTAD QM2/QM300 CONTROL C PACK (K880730)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-25
NOVA LITE(TM) DSDNA (K880742)Inova Diagnostics, Inc.1988-03-25
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK (K880728)Kallestad Diag, A Div. of Erbamont, Inc.1988-03-25
IVT WESTERN ALLERGY SCREEN (K875328)In Vitro Technologies, Inc.1988-03-23
VISION(R) CRP (K875345)Abbott Laboratories1988-03-21
QUIDEL TOTAL IGE TEST (K875168)Quidel Corp.1988-03-18
LA ANTIBODY TEST KIT (K874195)Lipogen, Inc.1988-03-11
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST (K880003)Em Diagnostic Systems, Inc.1988-03-11
RNP ANTIBODY TEST KIT (K874152)Lipogen, Inc.1988-03-11
MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3 (K880001)3M Company1988-02-25
MODIFIED CRP LATEX TEST (K880016)Sclavo, Inc.1988-02-25
PROGENE(TM) IGE TEST (K875125)Progene Corp.1988-02-25
GULLSORB IGG INACTIVATION REAGENT (K875254)Gull Laboratories, Inc.1988-02-17
V-TREND IM DRY-SPOT TEST (K880399)Texas Immunology, Inc.1988-02-17
MAT (TM) MICROALBUMIN TEST (K875161)Wampole Laboratories1988-02-17
FLIPSCREEN QAT (K874802)Alerchek, Inc.1988-02-17
RRT TOTAL IGE TEST KIT (K874541)Incstar Corp.1988-02-17
N-IMMUNOGLOBULIN LIGHT CHAIN KIT (K880341)Behring Diagnostics, Inc.1988-02-17
MULTI-ALLERGEN IGE FAST SCREEN (MOLDS) (K880002)3M Company1988-02-17
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)) (K875274)Incstar Corp.1988-02-17
QM2/QM300 CONTROL B PACK (K875283)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-10
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK (K875281)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-10
INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST (K880148)Ampcor, Inc.1988-02-10
LIPOGEN ANA TEST KIT (K875246)Lipogen, Inc.1988-02-10
RF CARD TEST & RF LIQUID TEST (K880164)Ampcor, Inc.1988-02-10
IMMUNOGLOBULIN G & G SUBCLASSES (K875356)Birmingham1988-02-10
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 (K874873)Diagnostic Products Corp.1988-02-10
ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT (K875066)Dexall Biomedical Labs, Inc.1988-01-29
AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 (K874203)Amersham Corp.1988-01-27
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK (K875165)Kallestad Diag, A Div. of Erbamont, Inc.1988-01-22
QM300 KAPPA LIGHT CHAINS ANTIBODY PACK (K875164)Kallestad Diag, A Div. of Erbamont, Inc.1988-01-22
IVT NORTHEAST ALLERGY SCREEN (K874169)In Vitro Technologies, Inc.1988-01-11
IVT SOUTHEAST ALLERGY SCREEN (K874168)In Vitro Technologies, Inc.1988-01-11
MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL) (K874446)3M Company1987-12-30
RF DIPSTICK TEST KIT (K874151)Lipogen, Inc.1987-12-29
NDNA ANTIBODY TEST KIT (K874191)Lipogen, Inc.1987-12-18
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT (K874281)Medix Biotech, Inc.1987-12-18
I.M.N. LATEX (K874678)Biokit USA, Inc.1987-12-14
DIFFERENTIAL I.M. SCREENING TEST (K873297)Sclavo, Inc.1987-12-14
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM (K874572)Nichols Institute Diagnostics1987-12-02
REUMA TEST (K873782)Sclavo, Inc.1987-11-27
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 (K874406)Medix Biotech, Inc.1987-11-25
CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY (K874379)Cytotech, Inc.1987-11-25
LIVE OAK ALLERGEN DISC (K874440)Incstar Corp.1987-11-25
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES (K873708)Whittaker Bioproducts, Inc.1987-11-25
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 (K874031)Diagnostic Products Corp.1987-11-25
TOTAL IGE FAST (TM) TEST PACKAGE (K873998)3M Company1987-11-04
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT (K873064)Amtec Diagnostics International, Inc.1987-11-04
IMMUSTRIP(TM) SM ELISA TEST SYSTEM (K873741)Immunomedics, Inc.1987-11-04
FALSE RAGWEED ALLERGEN DISC (K874149)Incstar Corp.1987-11-04
JOHNSON GRASS ALLERGEN DISC (K874150)Incstar Corp.1987-11-04
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) (K874115)Sigma Diagnostics, Inc.1987-11-04
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT (K873730)Medix Biotech, Inc.1987-11-04
GIANT RAGWEED ALLERGEN DISC (K873969)Incstar Corp.1987-11-04
HAPTOGLOBIN (K873866)Unipath , Ltd.1987-10-20
EUROGENETICS CRP ELISA (K872539)Eurogenetics1987-10-20
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC (K872946)Pharmacia, Inc.1987-10-20
ALBUMIN IN SERUM (K873862)Unipath , Ltd.1987-10-20
IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST (K873814)Incstar Corp.1987-10-20
PHARMACIA IGE EIA (K873077)Pharmacia, Inc.1987-10-20
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC (K873112)Pharmacia, Inc.1987-10-20
BERMUDA GRASS ALLERGEN DISC (K873770)Incstar Corp.1987-10-20
ANTINUCLEAR ANTIBODY TEST (K872839)Cappel Diagnostics, Inc.1987-10-20
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (K873868)Unipath , Ltd.1987-10-20
TRANSFERRIN (K873867)Unipath , Ltd.1987-10-13
CRP (K873865)Unipath , Ltd.1987-10-13
IMMUNOGLOBULINS G (K873870)Unipath , Ltd.1987-10-13
IMMUNOGLOBULINS A (K873869)Unipath , Ltd.1987-10-13
IMMUNOGLOBULINS M (K873871)Unipath , Ltd.1987-10-13
ALBUMIN IN URINE (K873861)Unipath , Ltd.1987-10-13
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS (K873193)Pharmacia, Inc.1987-10-08
BAHIA ALLERGEN DISC (K873648)Incstar Corp.1987-10-08
MODIFIED PHADEBAS RAST/PHADEZYM RAST (K872280)Pharmacia, Inc.1987-10-07
CIBA CORNING MAGIC LITE FERRITIN (K873573)Ciba Corning Diagnostics Corp.1987-10-07
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