Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
2617–2640 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 13, 1987
SWEET VERNAL ALLERGEN DISC
K871723 · DHB
Incstar Corp.
Immunology · 70d
Cleared Jul 09, 1987
KALLESTAD QM300 IGM ANTIBODY PACK
K872237 · DFT
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 29d
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