meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
32
Latest Decision
1988-06-08

Clearances · page 26 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K881340 NOVA LITE(TM) AUTOANTIBODY CONTROLS Inova Diagnostics, Inc. LLL Class II 1988-06-08
K881174 RID PLATE READER The Binding Site, Ltd. JZQ Class I 1988-06-08
K880784 WAKO(TM) IGG-HA DIRECT Wako Chemicals USA, Inc. DEW Class II 1988-06-06
K881933 KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST Kallestad Diag, A Div. of Erbamont, Inc. JZO Class II 1988-06-06
K881828 IMMUNOGLOBULIN M TEST SYSTEM The Binding Site, Ltd. CFQ Class II 1988-06-06
K881379 WESBLOT RNP-SM TEST American Bionetics, Inc. LKP Class II 1988-05-16
K880899 PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA Pharmacia, Inc. DHB Class II 1988-05-16
K880168 INCSTAR'S BIRCH ALLERGEN DISC Incstar Corp. DHB Class II 1988-05-11
K874883 WALNUT ALLERGEN DISC Incstar Corp. DHB Class II 1988-05-11
K881345 IMX FERRITIN Abbott Laboratories DGD Class II 1988-05-11
K880221 INCSTAR'S PIGWEED ALLERGEN DISC Incstar Corp. DHB Class II 1988-05-11
K874540 MARSH ELDER ALLERGEN DISC Incstar Corp. DHB Class II 1988-05-11
K880719 PHARMACIA B2-MICRO RIA Pharmacia, Inc. JZG Class II 1988-04-21
K880897 NOVA GEL (TM) SCL-70 Inova Diagnostics, Inc. LLL Class II 1988-04-21
K880415 MESQUITE ALLERGEN DISC Incstar Corp. DHB Class II 1988-04-21
K880187 INCSTAR'S DANDELION ALLERGEN DISC Incstar Corp. DHB Class II 1988-04-21
K880567 WHITE ASH ALLERGEN DISC Incstar Corp. DHB Class II 1988-04-21
K881339 NOVA LITE(TM) ANA PLUS Inova Diagnostics, Inc. LLL Class II 1988-04-21
K875244 ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM Diagnostic Products Corp. DHB Class II 1988-04-21
K875163 GOLDENROD ALLERGEN DISC Incstar Corp. DHB Class II 1988-04-21
K881138 CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. Baxter Healthcare Corp JMG Class II 1988-04-21
K881127 QM300 CALIBRATOR D PACK Kallestad Diag, A Div. of Erbamont, Inc. DCF Class II 1988-04-21
K880160 DPC'S ALLERGEN-SPECIFIC IGE SYSTEM Diagnostic Products Corp. DHB Class II 1988-04-21
K881675 IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS Dynatech Laboratories, Inc. JZQ Class I 1988-04-21
K881247 MONO-PHILE Bio Diagnostic Systems, Inc. KTN Class II 1988-04-07
K880356 N PROTEIN STANDARD PLASMA (HUMAN) Behring Diagnostics, Inc. CFN Class II 1988-04-07
K875329 IVT CENTRAL ALLERGY SCREEN In Vitro Technologies, Inc. DHB Class II 1988-04-07
K881181 NOVA GEL(TM) SM/RNP Inova Diagnostics, Inc. LLL Class II 1988-04-06
K881126 QM300 ALBUMIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DCF Class II 1988-04-06
K880254 SM ANTIBODY TEST KIT Lipogen, Inc. LKP Class II 1988-04-06
K874717 QUIDEL ALLERGY SCREEN Quidel Corp. DHB Class II 1988-04-06
K880729 KALLESTAD QM300 CALIBRATOR C PACK Kallestad Diag, A Div. of Erbamont, Inc. DCK Class II 1988-03-30
K880803 WAKO(TM) IGA-HA DIRECT Wako Chemicals USA, Inc. CZP Class II 1988-03-29
K880736 NOVA LITE(TM) ANA Inova Diagnostics, Inc. LLL Class II 1988-03-25
K880742 NOVA LITE(TM) DSDNA Inova Diagnostics, Inc. DHN Class II 1988-03-25
K880728 KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DCN Class II 1988-03-25
K880896 NOVA GEL(TM) SS-A/SS-B Inova Diagnostics, Inc. LLL Class II 1988-03-25
K880547 VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY Ventrex Laboratories, Inc. DHB Class II 1988-03-25
K880828 WAKO(TM) IGM-HA DIRECT Wako Chemicals USA, Inc. DFT Class II 1988-03-25
K880730 KALLESTAD QM2/QM300 CONTROL C PACK Kallestad Diag, A Div. of Erbamont, Inc. DCK Class II 1988-03-25
K875328 IVT WESTERN ALLERGY SCREEN In Vitro Technologies, Inc. DHB Class II 1988-03-23
K875345 VISION(R) CRP Abbott Laboratories DCK Class II 1988-03-21
K875168 QUIDEL TOTAL IGE TEST Quidel Corp. DHB Class II 1988-03-18
K880003 ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST Em Diagnostic Systems, Inc. DHB Class II 1988-03-11
K874152 RNP ANTIBODY TEST KIT Lipogen, Inc. LKO Class II 1988-03-11
K874195 LA ANTIBODY TEST KIT Lipogen, Inc. LJM Class II 1988-03-11
K880016 MODIFIED CRP LATEX TEST Sclavo, Inc. DCK Class II 1988-02-25
K875125 PROGENE(TM) IGE TEST Progene Corp. DHB Class II 1988-02-25
K880001 MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3 3M Company DHB Class II 1988-02-25
K874541 RRT TOTAL IGE TEST KIT Incstar Corp. DGC Class II 1988-02-17
K874802 FLIPSCREEN QAT Alerchek, Inc. DHB Class II 1988-02-17
K875161 MAT (TM) MICROALBUMIN TEST Wampole Laboratories DCF Class II 1988-02-17
K880002 MULTI-ALLERGEN IGE FAST SCREEN (MOLDS) 3M Company DHB Class II 1988-02-17
K880399 V-TREND IM DRY-SPOT TEST Texas Immunology, Inc. KTN Class II 1988-02-17
K875274 TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)) Incstar Corp. DHB Class II 1988-02-17
K875254 GULLSORB IGG INACTIVATION REAGENT Gull Laboratories, Inc. DEW Class II 1988-02-17
K880341 N-IMMUNOGLOBULIN LIGHT CHAIN KIT Behring Diagnostics, Inc. DFH Class II 1988-02-17
K875281 QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DEM Class II 1988-02-10
K880164 RF CARD TEST & RF LIQUID TEST Ampcor, Inc. DHR Class II 1988-02-10
K874873 COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 Diagnostic Products Corp. DHN Class II 1988-02-10
K875283 QM2/QM300 CONTROL B PACK Kallestad Diag, A Div. of Erbamont, Inc. DEM Class II 1988-02-10
K875246 LIPOGEN ANA TEST KIT Lipogen, Inc. LJM Class II 1988-02-10
K875356 IMMUNOGLOBULIN G & G SUBCLASSES Birmingham DEW Class II 1988-02-10
K880148 INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST Ampcor, Inc. KTN Class II 1988-02-10
K875066 ADDITIONAL ALLERGENS FOR ALLERG*ENS EIA KIT Dexall Biomedical Labs, Inc. DHB Class II 1988-01-29
K874203 AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 Amersham Corp. DBF Class II 1988-01-27
K875164 QM300 KAPPA LIGHT CHAINS ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DFH Class II 1988-01-22
K875165 QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK Kallestad Diag, A Div. of Erbamont, Inc. DEH Class II 1988-01-22
K874168 IVT SOUTHEAST ALLERGY SCREEN In Vitro Technologies, Inc. DHB Class II 1988-01-11
K874169 IVT NORTHEAST ALLERGY SCREEN In Vitro Technologies, Inc. DHB Class II 1988-01-11
K874446 MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL) 3M Company DHB Class II 1987-12-30
K874151 RF DIPSTICK TEST KIT Lipogen, Inc. DHR Class II 1987-12-29
K874191 NDNA ANTIBODY TEST KIT Lipogen, Inc. LRM Class II 1987-12-18
K874281 MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT Medix Biotech, Inc. DHB Class II 1987-12-18
K874678 I.M.N. LATEX Biokit USA, Inc. KTN Class II 1987-12-14
K873297 DIFFERENTIAL I.M. SCREENING TEST Sclavo, Inc. KTN Class II 1987-12-14
K874572 ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM Nichols Institute Diagnostics DBF Class II 1987-12-02
K873782 REUMA TEST Sclavo, Inc. DHR Class II 1987-11-27
K874379 CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY Cytotech, Inc. CZY Class II 1987-11-25
K874031 IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 Diagnostic Products Corp. DBF Class II 1987-11-25
K873708 FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES Whittaker Bioproducts, Inc. LLL Class II 1987-11-25
K874406 IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 Medix Biotech, Inc. DGC Class II 1987-11-25
K874440 LIVE OAK ALLERGEN DISC Incstar Corp. DHB Class II 1987-11-25
K874150 JOHNSON GRASS ALLERGEN DISC Incstar Corp. DHB Class II 1987-11-04
K873998 TOTAL IGE FAST (TM) TEST PACKAGE 3M Company DHB Class II 1987-11-04
K874115 NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) Sigma Diagnostics, Inc. LKJ Class II 1987-11-04
K874149 FALSE RAGWEED ALLERGEN DISC Incstar Corp. DHB Class II 1987-11-04
K873730 MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT Medix Biotech, Inc. JMG Class II 1987-11-04
K873741 IMMUSTRIP(TM) SM ELISA TEST SYSTEM Immunomedics, Inc. LKP Class II 1987-11-04
K873969 GIANT RAGWEED ALLERGEN DISC Incstar Corp. DHB Class II 1987-11-04
K873064 AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT Amtec Diagnostics International, Inc. DHR Class II 1987-11-04
K873770 BERMUDA GRASS ALLERGEN DISC Incstar Corp. DHB Class II 1987-10-20
K873868 ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) Unipath , Ltd. LKL Class I 1987-10-20
K873814 IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST Incstar Corp. DHB Class II 1987-10-20
K872539 EUROGENETICS CRP ELISA Eurogenetics DCN Class II 1987-10-20
K872946 PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC Pharmacia, Inc. DHB Class II 1987-10-20
K873866 HAPTOGLOBIN Unipath , Ltd. DAD Class II 1987-10-20
K873077 PHARMACIA IGE EIA Pharmacia, Inc. JHR Class II 1987-10-20
K873862 ALBUMIN IN SERUM Unipath , Ltd. DCF Class II 1987-10-20
K872839 ANTINUCLEAR ANTIBODY TEST Cappel Diagnostics, Inc. LJM Class II 1987-10-20

3,548 clearances in the Immunology panel. Data: openFDA.