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
2617–2640 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 29, 1987
VENTRESCREEN (TM) MONO
K872032 · KTN
Ventrex Laboratories, Inc.
Immunology · 33d
Cleared Jun 18, 1987
QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL
K872078 · DER
Solomon Park Research Laboratories
Immunology · 20d
Cleared Jun 15, 1987
TINA-QUANT [A] CRP
K871895 · DCK
Boehringer Mannheim Corp.
Immunology · 31d
Cleared Jun 15, 1987
TINA-QUANT [A] TRANSFERRIN
K871896 · DDG
Boehringer Mannheim Corp.
Immunology · 31d
Cleared Jun 15, 1987
RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS
K872079 · MSJ
Reagents Applications, Inc.
Immunology · 17d
Cleared Jun 15, 1987
RAICHEM(TM) SPIA(TM) APO B REAGENTS
K872080 · DFC
Reagents Applications, Inc.
Immunology · 17d
Cleared Jun 12, 1987
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
K871489 · DBF
Diagnostic Systems Laboratories, Inc.
Immunology · 58d
Cleared Jun 12, 1987
DELFIA(TM) HIGE KIT
K871599 · DHB
Lkb Instruments, Inc.
Immunology · 49d
Cleared Jun 12, 1987
QM300 C3 ANTIBODY PACK
K871939 · CZW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared Jun 12, 1987
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
K871940 · CZP
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 25d
Cleared Jun 09, 1987
CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
K871801 · DHN
Cytotech, Inc.
Immunology · 32d
Cleared May 21, 1987
TRI-LEVEL LIGAND CONTROL
K864877 · DHX
Ciba Corning Diagnostics Corp.
Immunology · 160d
Cleared May 21, 1987
QM300 CALIBRATOR A PACK
K871341 · JIX
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 21, 1987
QM2/QM300 CONTROL A PACK
K871342 · JJY
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 49d
Cleared May 15, 1987
PRECIMAT(R) C3
K871024 · CZW
Boehringer Mannheim Corp.
Immunology · 60d
Cleared May 15, 1987
PRECINORM(R) PROTEIN
K871027 · DAF
Boehringer Mannheim Corp.
Immunology · 60d
Cleared May 15, 1987
I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT
K871193 · JZO
Cronus
Immunology · 52d
Cleared May 15, 1987
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
K871339 · JQP
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared May 15, 1987
QM2/QM300 BUFFER AND DILUENT PACK
K871343 · CFN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared May 14, 1987
IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM
K870903 · LRM
Immunomedics, Inc.
Immunology · 70d
Cleared May 14, 1987
PRECIMAT(R) TRANSFERRIN
K871022 · DDG
Boehringer Mannheim Corp.
Immunology · 59d
Cleared May 14, 1987
PRECIMAT(R) C4
K871023 · DBI
Boehringer Mannheim Corp.
Immunology · 59d
Cleared May 14, 1987
WESTERN RAGWEED ALLERGEN DISC
K871660 · DHB
Incstar Corp.
Immunology · 16d
Cleared May 06, 1987
PRECIMAT(R) CRP
K871055 · DCK
Boehringer Mannheim Corp.
Immunology · 50d