Atlas FDA

Immunology

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

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RecordFirmDate
IMX B2-MICROGLOBULIN (K890421)Abbott Laboratories1989-03-09
FLIPSCREEN (TM) TOTAL E IMMUNOASSAY (K885307)Alerchek, Inc.1989-03-08
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4 (K890675)Unipath , Ltd.1989-03-06
SPQ(TM) ANTIBODY REAGENT SET II FOR TRF (K890563)Atlantic Antibodies1989-03-03
SPQ(TM) ANTIBODY REAGENT SET II FOR IGM (K890561)Atlantic Antibodies1989-02-23
SPQ(TM) ANTIBODY REAGENT SET II FOR IGG (K890416)Atlantic Antibodies1989-02-22
SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (K890562)Atlantic Antibodies1989-02-22
SPQ(TM) ANTIBODY REAGENT SET II FOR C3 (K890417)Atlantic Antibodies1989-02-17
SPQ(TM) ANTIBODY REAGENT SET II FOR AAT (K890415)Atlantic Antibodies1989-02-17
SPQ(TM) ANTIBODY REAGENT SET II FOR C4 (K890564)Atlantic Antibodies1989-02-17
QUIDEL FOOD ALLERGY SCREEN (K884501)Quidel Corp.1989-02-17
V-TREND TARGET CRP TEST (K890423)Texas Immunology, Inc.1989-02-17
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA (K890560)Atlantic Antibodies1989-02-15
ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS (K885269)Dexall Biomedical Labs, Inc.1989-02-07
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (K884180)Unipath , Ltd.1989-02-03
ACCESS R-CLONE ANA PROFILE ASSAY (K885048)Lipogen, Inc.1989-01-24
V-TREND TARGET IM TEST (K890041)Texas Immunology, Inc.1989-01-23
28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM) (K884883)Diagnostic Products Corp.1989-01-23
MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM) (K884923)Diagnostic Products Corp.1989-01-11
BERICHROM(R) PLASMINOGEN (K884766)Behring Diagnostics, Inc.1989-01-04
IGE FASTSCREEN S6 (F1, F2, F4, F13, F14) (K885065)3M Company1989-01-04
AFFINITY(TM) FERRITIN IMMUNIT(TM) (K885074)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-01-04
FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY (K884683)Serono-Baker Diagnostics, Inc.1988-12-27
QM300 PCR ANTIBODY PACK (K885001)Kallestad Diag, A Div. of Erbamont, Inc.1988-12-20
MODIFICATION OF MONO-PLUS(TM) (K883709)Armkel, LLC1988-12-20
BECKMAN LAMBDA LIGHT CHAIN REAGENT (K884597)Beckman Instruments, Inc.1988-12-06
CARDS(TM) MONO (K884007)Pacific Biotech, Inc.1988-11-18
BECKMAN KAPPA LIGHT CHAIN REAGENT (K884276)Beckman Instruments, Inc.1988-11-16
RIA/MAT FPA TEST KIT (K884496)Altana, Inc.1988-11-16
DELFIA (TM) HIGE KIT (K884545)Pharmacia, Inc.1988-11-10
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN (K884217)Technicon Instruments Corp.1988-11-04
ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) (K884400)Immco Diagnostics, Inc.1988-11-04
QM300 CONTROL E (K883537)Kallestad Diag, A Div. of Erbamont, Inc.1988-11-04
SPQ(TM) TEST SYSTEM FOR MICROALBUMIN (K884298)Atlantic Antibodies1988-11-02
SPQ(TM) TEST SYSTEM FOR PREALBUMIN (K884297)Atlantic Antibodies1988-11-02
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (K884147)Orion Diagnostica, Inc.1988-10-27
MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10) (K883371)3M Company1988-10-27
MICROMEDIC FERRITIN IRMA KIT (K883746)Icn Micromedic Systems1988-10-27
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT) (K883949)Immco Diagnostics, Inc.1988-10-27
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS) (K883883)Immco Diagnostics, Inc.1988-10-27
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (K884074)Orion Diagnostica, Inc.1988-10-27
CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY (K884185)Ciba Corning Diagnostics Corp.1988-10-27
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A (K884040)Orion Diagnostica, Inc.1988-10-19
IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (K884075)Orion Diagnostica, Inc.1988-10-19
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR (K884101)E.I. Dupont DE Nemours & Co., Inc.1988-10-19
OXOID INFECTIOUS MONONUCLEOSIS KIT (K883540)Unipath , Ltd.1988-10-19
AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) (K883915)Immco Diagnostics, Inc.1988-10-19
QUIDEL ALLERGY SCREEN (K883666)Quidel Corp.1988-10-18
MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL (K881259)Triton Biosciences, Inc.1988-10-12
QM300 CONTROL F PACK (K883712)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
TECHNICON DPA-1 IMMUNOGLOBULIN M (K883493)Technicon Instruments Corp.1988-09-22
TECHNICON DPA-1 IMMUNOGLOBULIN A (K883492)Technicon Instruments Corp.1988-09-22
QM300 CALIBRATOR D PACK (K883001)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
NOVA LITE(TM) SA (K881341)Inova Diagnostics, Inc.1988-09-22
ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAY (K882740)Lipogen, Inc.1988-09-22
QM300 CALIBRATOR F PACK (K883711)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
DU PONT DIMENSION C-REACTIVE PROTEIN METHOD (K883515)E.I. Dupont DE Nemours & Co., Inc.1988-09-22
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) (K883616)Diagnostic Products Corp.1988-09-22
QM300 PREALBUMIN ANTIBODY PACK (K883002)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-22
UBI MAGIWEL RF-IGM QUANTITATIVE (K883355)United Biotech, Inc.1988-09-07
DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) (K883273)3M Company1988-09-07
QM300 CALIBRATOR E PACK (K883538)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-07
QM300 RHEUMATOID FACTOR ANTIGEN PACK (K883536)Kallestad Diag, A Div. of Erbamont, Inc.1988-09-07
TECHNICON DPA-1 IMMUNOGLOBULIN G (K883494)Technicon Instruments Corp.1988-09-07
ACUTE PHASE C-REACTIVE PROTEIN LATEX AGGLU. TEST (K882998)Amtec Diagnostics International, Inc.1988-09-07
HISTONE REACTIVE ANA (K883232)Val Tech Diagnostics, Inc.1988-09-07
QLIA IMMUNOCHEMISTRY SYSTEM (K883349)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-09-07
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS. (K881899)Diagnostic Products Corp.1988-08-10
PHARMACIA IGE RIA ULTRA (K882625)Pharmacia, Inc.1988-08-08
CIRCULATING IMMUNE COMPLEXES CONTROLS (K882829)Cytotech, Inc.1988-08-04
FIAGEN FERRITIN (K882822)Cyberfluor, Inc.1988-08-04
MONO-PLUS(TM) (K883004)Wampole Laboratories1988-08-04
ALTERNATE PROCEDURE, PHARMACIA IGE EIA (K882616)Pharmacia, Inc.1988-08-04
PHARMACIA IGE EIA ULTRA (K882626)Pharmacia, Inc.1988-08-04
TECHNICON DPA-1(TM) SYSTEM (K882153)Technicon Instruments Corp.1988-08-04
ACCRAASSAY RID KITS (K882369)Icn Immunobiologicals1988-07-12
STAT-20 FLUOROMETER (K882677)Weaver Medical1988-07-12
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM (K882622)Technicon Instruments Corp.1988-07-08
QM300 IGG ANTIBODY PACK (K882083)Kallestad Diag, A Div. of Erbamont, Inc.1988-07-08
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM (K882621)Technicon Instruments Corp.1988-07-08
MONOCLONAL RADIAL IMMUNODIFFUSION KIT (K881928)The Binding Site, Ltd.1988-07-08
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM (K882446)Technicon Instruments Corp.1988-07-08
WAKO(TM) CRP (K882374)Wako Chemicals USA, Inc.1988-07-08
PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM (K882623)Technicon Instruments Corp.1988-07-08
QM300 ALBUMIN ANTIBODY PACK (K882082)Kallestad Diag, A Div. of Erbamont, Inc.1988-07-08
ANTI-CYTOKERATIN MONOCLONAL ANTIBODY (K864893)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-07-07
HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC (K875110)Incstar Corp.1988-06-14
PHARMACIA IGE RIACT (K881892)Pharmacia, Inc.1988-06-10
IMMUNOGLOBULIN A TEST SYSTEM (K881827)The Binding Site, Ltd.1988-06-10
NOVA LITE(TM) AUTOANTIBODY CONTROLS (K881340)Inova Diagnostics, Inc.1988-06-08
RID PLATE READER (K881174)The Binding Site, Ltd.1988-06-08
IMMUNOGLOBULIN M TEST SYSTEM (K881828)The Binding Site, Ltd.1988-06-06
WAKO(TM) IGG-HA DIRECT (K880784)Wako Chemicals USA, Inc.1988-06-06
KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST (K881933)Kallestad Diag, A Div. of Erbamont, Inc.1988-06-06
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA (K880899)Pharmacia, Inc.1988-05-16
WESBLOT RNP-SM TEST (K881379)American Bionetics, Inc.1988-05-16
INCSTAR'S BIRCH ALLERGEN DISC (K880168)Incstar Corp.1988-05-11
INCSTAR'S PIGWEED ALLERGEN DISC (K880221)Incstar Corp.1988-05-11
MARSH ELDER ALLERGEN DISC (K874540)Incstar Corp.1988-05-11
IMX FERRITIN (K881345)Abbott Laboratories1988-05-11
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