FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
3745–3768 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 16, 1976
GAMMA SCINTILLATION COUNTER
K760900 · JJJ
Beckman Instruments, Inc.
Immunology · 21d
Cleared Nov 16, 1976
LAS-R HUMAN ALPHA, ANTITRYPSIN TEST
K760916 · DEM
Hyland Therapeutic Div., Travenol...
Immunology · 19d
Cleared Nov 12, 1976
BIOCEPT-G
K760336 · JHI
Wampole Laboratories
Immunology · 105d
Cleared Nov 09, 1976
FEBRILE ANTIGEN CONTROL SERA
K760881 · GSZ
Bd Becton Dickinson Vacutainer...
Immunology · 19d
Cleared Nov 09, 1976
STERILE DISPOSABLE COTTON PLUGGED SER.
K760899 · GJW
Bd Becton Dickinson Vacutainer...
Immunology · 14d
Cleared Nov 01, 1976
RADIOASSAY KIT, IM.72 FSH
K760373 · CGJ
Amersham Corp.
Immunology · 88d
Cleared Nov 01, 1976
TSH RIA KIT
K760801 · JLW
Diagnostic Products Corp.
Immunology · 20d
Cleared Nov 01, 1976
HISTOPLASMA MYCELIAL ANTIGEN
K760826 · GMJ
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
HISTOPLASMA YEAST ANTIGEN
K760827 · GMJ
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
BLASTOMYCES YEAST ANTIGEN
K760828 · JJJ
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
COCCIDIOIDES MYCELIAL ANTIGEN
K760829 · GMG
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ASPERGILLUS MYCELIAL ANTIGEN
K760830 · JWT
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL)
K760831 · GMK
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-HISTOPLASMA CONTROL SERUM (YEAST)
K760832 · GMK
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-BLASTOMYCES CONTROL SERUM (YEAST)
K760833 · KFH
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL)
K760834 · GMH
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
ANTI-ASPERGILLUS CONT. SER. (MYCELIAL)
K760835 · KFG
I M, Inc.
Immunology · 19d
Cleared Nov 01, 1976
NEGATIVE CONTROL SERUM
K760836
I M, Inc.
Immunology · 19d
Cleared Oct 29, 1976
T-3 UPTAKE KIT
K760802 · KHQ
Diagnostic Products Corp.
Immunology · 17d
Cleared Oct 21, 1976
INDIRECT FLUORESCENT (IFA-ANA)
K760681 · DHN
Wampole Laboratories
Immunology · 31d
Cleared Oct 08, 1976
HA ANTIGEN
K760606
Flow Laboratories, Inc.
Immunology · 29d
Cleared Oct 08, 1976
HI CHICKEN ANTISERUM
K760607
Flow Laboratories, Inc.
Immunology · 29d
Cleared Oct 08, 1976
HI CHICKEN PRESERUM
K760608
Flow Laboratories, Inc.
Immunology · 29d
Cleared Sep 13, 1976
TEST, RIA, TRIODOTHYRONINE
K760057 · CDP
Smithkline Diagnostics, Inc.
Immunology · 89d