ClearanceBrief
Panels › Immunology › Product code DHN · Class 2

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Regulation 866.5100

0510(k)s in 12 months (110 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Get daily alerts for DHNSample briefCSV

Top companies in DHN

Company510(k)sRecalls
Bio-Rad140
Immuno Concepts, Inc.71
Zeus Scientific, Inc.60
Inova Diagnostics, Inc.41
Meloy Laboratories, Inc.50
Euroimmun US30
Amico Lab, Inc.20
Apple Diagnostic Products20
Behring Diagnostics, Inc.20
Bio-Rad Laboratories02
Decided510(k)Device and applicantCode
Apr 20, 1987K871395DUAL SUBSTRATE ANA
Val Tech Diagnostics, Inc.
DHN
Mar 17, 1987K870458HISTONES EIA DIAGNOSTIC KIT
Biohytech International, Inc.
DHN
Mar 10, 1987K870732RAT LIVER NUCLEI TEST SYSTEM
Val Tech Diagnostics, Inc.
DHN
Oct 24, 1986K863717ANTI-DNA MICROASSAY
Diamedix Corp.
DHN
Aug 15, 1986K862821CAPPEL DIAGNOSTICS ANA KIT
Cappel Diagnostics, Inc.
DHN
Feb 26, 1986K860183AFT-HEP SYSTEM
Behring Diagnostics, Inc.
DHN
Dec 16, 1985K854314FANA 60
American Bio-Reagents, Inc.
DHN
Jun 21, 1985K852033SS-A(RO) & SS-B(LA) ANTIBODY ASSAY
Meloy Laboratories, Inc.
DHN
May 15, 1985K851369ANTINUCLEAR ANTIBODY TEST KIT
Modern Diagnostics, Inc.
DHN
Mar 14, 1985K842991AUTOFLUOR V SYSTEM
Tech America Diagnostics
DHN
Jan 4, 1985K844678MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CUL
Meloy Laboratories, Inc.
DHN
Nov 1, 1984K843225COLORZYME NDNA TEST SYSTEM
Immuno Concepts, Inc.
DHN
Nov 1, 1984K841984AUTOFLOUR III SYSTEM
Tech America Diagnostics
DHN
Oct 5, 1984K843347RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON
E.I. Dupont DE Nemours & Co., Inc.
DHN
Jun 22, 1984K842183ADP ANA IFA TEST
Apple Diagnostic Products
DHN
Jun 22, 1984K841776ANA SENSITIVITY/SPECIFICITY CONTROL
Behring Diagnostics, Inc.
DHN
Apr 25, 1984K841127VIRGO REAGENTS INDIRECT FLUORSCENT
Electro-Nucleonics Laboratories, Inc.
DHN
Apr 4, 1984K834241ANA APPLELISA
Apple Diagnostic Products
DHN
Nov 21, 1983K833119AUTOIMMUNE TEST 1/2/3 SYSTEM
Atlantic Antibodies
DHN
Aug 31, 1983K832383IDT ANA STIQ ASSAY
Intl. Diagnostic Technology
DHN
Jul 28, 1983K831408DNA FLOR
Medastat Scientific Corp.
DHN
Apr 27, 1983K831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUB
Immuno-Products Industries
DHN
Mar 9, 1983K830214AFT SYSTEM III
Calbiochem-Behring Corp.
DHN
Dec 13, 1982K822681ANTI-NUCLEAR ANTIBODY TEST KIT (ANA)
Amico Lab, Inc.
DHN
Dec 3, 1982K822682ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
Amico Lab, Inc.
DHN
Nov 5, 1982K823055FLOUROSET IMMUNOFLUORESCENT ANTIBODY
Immulok, Inc.
DHN
Oct 26, 1982K820945SERA FOR ANTINUCLEAR ANTIBODIES
Centers for Disease Control and Prevention
DHN
Sep 21, 1982K822397ANA HEP-2 FLUORO-KIT
Clinical Sciences, Inc.
DHN
Sep 17, 1982K822607ANTINUCLEAR ANTOBODY CELL SUBSTRATE
Immulok, Inc.
DHN
Feb 12, 1982K820265ANA TEST (MOUSE LIVER SUBSTRATE)
Meloy Laboratories, Inc.
DHN
Jan 18, 1982K813592QUANTAFLUOR FLUORESCENT TEST REAGENTS
Kallestad Laboratories, Inc.
DHN
Sep 1, 1981K812314CRITHIDNA ANTI-DNA TEST KIT
Antibodies, Inc.
DHN
Jul 10, 1981K811714HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
Scripps-Miles, Inc.
DHN
May 1, 1981K810985ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT
Immuno-Products Industries
DHN
Apr 23, 1981K811022ANA TEST KIT
Immuno-Diagnostic Products, Inc.
DHN
Feb 25, 1981K810301CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST
Immuno Concepts, Inc.
DHN
Feb 9, 1981K810081SCRIPPSERA ANA REFERENCE CONTROL SERA
Scripps-Miles, Inc.
DHN
Jan 29, 1981K802299K/K (ASMA/ANA) UNIVERSAL BIOPAK
Bioware Products
DHN
Jan 26, 1981K803276ANA-IFA TEST SYSTEM
Immuno Concepts, Inc.
DHN
Jan 5, 1981K802527TEST KIT FOR DETECTION OF ANTINUCLEAR
Bartels & Stout, Inc.
DHN
May 14, 1980K801046ANATON
Armkel, LLC
DHN
Nov 30, 1979K792184LAB-TEK ANA TEST KIT
Miles Laboratories, Inc.
DHN
Nov 13, 1979K791928ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
Keith E. Abbott
DHN
Oct 30, 1979K791995ANTI NUCLEAR ANTIBODY TEST
Meda Stat Diagnostics, Inc.
DHN
Sep 24, 1979K791493ANTI-NUCLEAR ANTIBODY TEST
Meloy Laboratories, Inc.
DHN
Apr 23, 1979K790280AUTOANTIBODY REAGENTS, AFT SYSTEM II
Calbiochem-Behring Corp.
DHN
Mar 15, 1979K790252ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI
Meloy Laboratories, Inc.
DHN
Jan 17, 1979K782048TEST KIT, IIF-ANA
Medica Corp.
DHN
Jan 3, 1979K782041FIAX TEST KIT
Idt, A Division of Whittaker M.A. Bioproducts
DHN
Sep 7, 1978K780899FLUORESCENT ANTI-NATIVE DNA TEST
Kallestad Laboratories, Inc.
DHN

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.