meddevicedb.com FDA Device Reference

Review Panel

Immunology FDA 510(k) Clearances & Devices

Cleared Devices
3,548
Product Codes (page)
40
Latest Decision
1997-10-29

Clearances · page 16 of 36

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K971690 IMMUNOSCAN PR3-ANCA Euro-Diagnostica AB MOB Class II 1997-10-29
K973331 VITROS IMMUNODIAGNOSTIC PRODUCTS FERRITIN REAGENT PACK (GEM.1340), FERRITIN CALIBRATORS (GEM.C340) Ortho-Clinical Diagnostics, Inc. DBF Class II 1997-10-22
K973464 QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) Instrumentation Laboratory CO DHR Class II 1997-10-22
K973014 QUANTA LITE B2GPI IGM Inova Diagnostics, Inc. MSV Class II 1997-10-20
K972929 N ANTISERUM TO HUMAN ALBUMIN Behring Diagnostics, Inc. DCF Class II 1997-10-20
K972200 ANEUVYSION Vysis OYU Class II 1997-10-20
K940583 VENTANA CD45 PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1997-10-20
K973006 QUANTA LITE B2 GPI IGA Inova Diagnostics, Inc. MSV Class II 1997-10-20
K972840 N ANTISERUM TO HUMAN TRANSFERRIN Behring Diagnostics, Inc. DDG Class II 1997-10-17
K973392 CHEMMATE LAMBDA Ventana Medical Systems, Inc. DEM Class II 1997-10-03
K972697 AIA-PACK IGE II ASSAY Tosoh Medics, Inc. DGC Class II 1997-10-03
K973390 CHEMMATE L26 (CD20) Ventana Medical Systems, Inc. DEM Class II 1997-10-03
K973389 CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING Ventana Medical Systems, Inc. DEM Class II 1997-10-03
K973391 CHEMMATE KAPPA Ventana Medical Systems, Inc. DEM Class II 1997-10-03
K973189 RETINOL BINDING PROTEIN RBP RID KIT The Binding Site, Ltd. CZS Class I 1997-09-29
K973186 IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE Diagnostic Products Corp. DHB Class II 1997-09-29
K973393 CHEMMATE LCA Ventana Medical Systems, Inc. DEH Class II 1997-09-25
K972462 AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. LOJ Class II 1997-09-22
K970877 IMMULITE CEA Diagnostic Products Corp. DHX Class II 1997-09-22
K973101 PROSTATE SPECIFIC ANTIGEN METHOD Dade Chemistry Systems, Inc. LTJ Class II 1997-09-18
K963926 AXSYM CA 15-3 Abbott Laboratories MOI Class II 1997-09-15
K973202 MODIFICATION OF OPUS FERRITIN TEST SYSTEM Behring Diagnostics, Inc. DBF Class II 1997-09-12
K972220 RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT Randox Laboratories, Ltd. DHR Class II 1997-09-09
K972364 UNICAP PHADIATOP Pharmacia, Inc. DHB Class II 1997-09-04
K972812 RAICHEM PREALBUMIN SPIA Hemagen Diagnostics, Inc. DDS Class I 1997-08-28
K972231 OSOM MONO TEST 143 Wyntek Diagnostics, Inc. KTN Class II 1997-08-26
K972095 IMMULITE 2000 PSA Diagnostic Products Corp. LTJ Class II 1997-08-22
K971958 SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT Beckman Instruments, Inc. DDG Class II 1997-08-20
K970695 ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29) Chiron Diagnostics Corp. MOI Class II 1997-08-08
K972160 CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST Trinity Laboratories, Inc. DCK Class II 1997-08-01
K964292 N-ASSAY TIA APO A1 TEST KIT Crestat Diagnostics, Inc. DER Class II 1997-08-01
K964296 N-ASSAY TIA APO B TEST KIT Crestat Diagnostics, Inc. DER Class II 1997-08-01
K964294 N-ASSAY TIA APO A1/B MULTI CALIBRATOR Crestat Diagnostics, Inc. DER Class II 1997-08-01
K964282 TINA-QUANT FERRITIN ASSAY Boehringer Mannheim Corp. JMG Class II 1997-07-30
K972513 TINAQUANT MYOGLOBIN ASSAY Boehringer Mannheim Corp. DDR Class II 1997-07-28
K964351 ELECSYS PSA ASSAY Boehringer Mannheim Corp. LTJ Class II 1997-07-25
K971784 ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM Zeus Scientific, Inc. MID Class II 1997-07-23
K971418 CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER Chiron Diagnostics Corp. MOI Class II 1997-07-17
K965024 N-ASSAY TIA C1-INACTIVATOR TEST KIT Crestat Diagnostics, Inc. DBA Class II 1997-07-14
K972190 THYROGLOBULIN ASSAY SYSTEM American Laboratory Products Co., Ltd. JZO Class II 1997-07-14
K964301 N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. DAD Class II 1997-07-14
K964297 N-ASSAY TIA C4 TEST KIT Crestat Diagnostics, Inc. DBI Class II 1997-07-14
K965100 N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT Crestat Diagnostics, Inc. DEM Class II 1997-07-14
K964298 N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. CZW Class II 1997-07-14
K964300 N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. DBI Class II 1997-07-14
K964299 N-ASSAY TIA MULTI V-NL Crestat Diagnostics, Inc. LKL Class I 1997-07-14
K972068 UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 Pharmacia, Inc. DHB Class II 1997-07-03
K965110 N-ASSAY TIA MULTI CRP CALIBRATOR SET Crestat Diagnostics, Inc. DCK Class II 1997-07-03
K971834 ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA Monobind JNL Class II 1997-07-03
K971835 ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA Monobind DDC Class II 1997-07-03
K971602 ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT Beckman Instruments, Inc. DHR Class II 1997-06-27
K970551 QUANTA LITE B2GPI IGG Inova Diagnostics, Inc. MSV Class II 1997-06-24
K970612 SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY Sealite Sciences, Inc. DBF Class II 1997-06-24
K964595 OPUS PSA TEST SYSTEM Behring Diagnostics, Inc. LTJ Class II 1997-06-24
K971614 QUANTA LITE RF IGM Inova Diagnostics, Inc. DHR Class II 1997-06-20
K971909 VIRGO AMA ELISA KIT Hemagen Diagnostics, Inc. DBM Class II 1997-06-20
K971379 TINAQUANT RHEUMATOID FACTOR ASSAY Boehringer Mannheim Corp. DHR Class II 1997-06-17
K964295 N-ASSAY TIA TRANSFERRIN TEST KIT Crestat Diagnostics, Inc. DDG Class II 1997-06-16
K964842 IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT Beckman Instruments, Inc. CZW Class II 1997-06-11
K970177 ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA Immco Diagnostics, Inc. MID Class II 1997-06-11
K971039 HEMAGEN ANTI CARDIOLIPIN SCREEN Hemagen Diagnostics, Inc. MID Class II 1997-06-03
K971788 SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR Beckman Instruments, Inc. DHR Class II 1997-06-03
K964986 QUANTA LITE IGA GLIADIN ELISA Inova Diagnostics, Inc. MST Class II 1997-06-02
K971833 ELECSYS FERRITIN Boehringer Mannheim Corp. JMG Class II 1997-06-02
K964341 IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT Immco Diagnostics, Inc. MST Class II 1997-05-30
K964985 QUANTA LITE IGG GLIADIN ELISA Inova Diagnostics, Inc. MST Class II 1997-05-30
K964344 IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT Immco Diagnostics, Inc. MST Class II 1997-05-30
K964767 QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( R&D Systems, Inc. JZG Class II 1997-05-29
K964791 B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) Bayer Corp. JZG Class II 1997-05-29
K970718 QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) R&D Systems, Inc. JNM Class II 1997-05-27
K963803 CENTOCOR CA 15-3 RIA MODEL NO. 800-033 Centocor, Inc. MOI Class II 1997-05-23
K971658 MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT Jay H. Geller DBL Class II 1997-05-23
K965094 HYCOR ALLERGEN DISC Hycor Biomedical, Inc. DHB Class II 1997-05-21
K965133 ANCA COMBI DIAGNOSTIC TEST KIT The Binding Site, Ltd. MOB Class II 1997-05-21
K964781 IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT Beckman Instruments, Inc. DDS Class I 1997-05-09
K970353 AURA TEK FDP Perimmune, Inc. MMW Class II 1997-04-30
K964695 IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT Beckman Instruments, Inc. DCF Class II 1997-04-29
K964762 IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT Beckman Instruments, Inc. DDB Class II 1997-04-25
K964766 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) Beckman Instruments, Inc. DEM Class II 1997-04-25
K941514 VENTANA ANTI-S100 PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1997-04-25
K964152 UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH Pharmacia, Inc. DGC Class II 1997-04-23
K941170 VENTANA ANTI-MELANOMA PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1997-04-22
K965033 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT Beckman Instruments, Inc. MGA Class I 1997-04-21
K941707 ANTI-MUSCLE ACTIN PRIMARY ANTIBODY Ventana Medical Systems, Inc. DEH Class II 1997-04-21
K970373 RAICHEM RHEUMATOID FACTOR SPIA Henage Diagnostics, Inc. DHR Class II 1997-04-17
K964151 BARD AND BTA TEST Bard Diagnostic Sciences,Inc. MMW Class II 1997-04-16
K964446 MYELOPEROXIDASE ELISA TEST SYSTEM Zeus Scientific, Inc. MOB Class II 1997-04-10
K964449 ANCA SCREEN ELISA TEST SYSTEM Zeus Scientific, Inc. MOB Class II 1997-04-10
K964448 PROTEINASE-3 IGG ELISA TEST SYSTEM Zeus Scientific, Inc. MOB Class II 1997-04-10
K970220 IS-ANTI-SM TEST SYSTEM Diamedix Corp. LLL Class II 1997-04-08
K970228 IS-ANTI-JO-1 TEST SYSTEM Diamedix Corp. LLL Class II 1997-04-08
K964787 MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM Mardx Diagnostics, Inc. LLL Class II 1997-04-08
K970237 IS-ANTI-SSB TEST SYSTEM (720-260) Diamedix Corp. LLL Class II 1997-04-08
K970218 IS-ANTI-SSA TEST SYSTEM Diamedix Corp. LLL Class II 1997-04-08
K970239 IS-ANTI-SCL-70 TEST SYSTEM (720-280) Diamedix Corp. LLL Class II 1997-04-08
K970238 IS-ANTI-SM/RNP (720-270) Diamedix Corp. LLL Class II 1997-04-08
K964257 IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT Beckman Instruments, Inc. LKL Class I 1997-03-24
K963976 IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT Beckman Instruments, Inc. DDG Class II 1997-03-19
K965085 ENZYMUN-TEST PSA Boehringer Mannheim Corp. LTJ Class II 1997-03-19
K962727 HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY Hycor Biomedical, Inc. LLL Class II 1997-03-07

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