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
3001–3024 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 23, 1984
IMMPULSE SYSTEM
K834070 · JZT
Paragon Diagnostics, Inc.
Immunology · 119d
Cleared Mar 23, 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · DGC
Pharmacia, Inc.
Immunology · 44d
Cleared Mar 23, 1984
CRP SLIDE TEST KIT
K840699 · DCN
Difco Laboratories, Inc.
Immunology · 36d
Cleared Mar 16, 1984
ROTAVIRUS BIO-ENZABEAD SCREEN KIT
K834443 · LIQ
Litton Bionetics
Immunology · 91d
Cleared Mar 12, 1984
CHYMOFAST TEST
K833418 · DHB
Allergenetics
Immunology · 161d
Cleared Mar 12, 1984
ORTHO BACTERIURIA DETECTION SYS
K833834 · JXA
Ortho Diagnostic Systems, Inc.
Immunology · 130d
Cleared Mar 12, 1984
CAT. 16-IMMUNOLOGY DEVICES
K840320 · HTD
Imm Enterprises , Ltd.
Immunology · 48d
Cleared Mar 09, 1984
ALLERCOAT MULTISCREEN DISCS
K840360 · DHB
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Mar 09, 1984
DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO
K840404 · DAD
Tago, Inc.
Immunology · 38d
Cleared Mar 02, 1984
ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS
K834242 · LJP
Apple Diagnostic Products
Immunology · 87d
Cleared Mar 02, 1984
DAT TEST FOR CHAGAS' DISEASE
K834328 · GNE
Sero-Immuno Diagnostics, Inc.
Immunology · 84d
Cleared Mar 02, 1984
PHADEBACT CSF POSITIVE CONTROLS
K840048 · GTY
Pharmacia, Inc.
Immunology · 56d
Cleared Feb 27, 1984
NABI CRP-Q.S. TEST
K834584 · DCN
Intl. Diagnostic, Inc.
Immunology · 60d
Cleared Feb 13, 1984
NABI RF-Q.S. TEST
K840005 · DHR
Intl. Diagnostic, Inc.
Immunology · 40d
Cleared Feb 10, 1984
VZV BIO-ENZABEAD SCREEN KIT
K833637 · LFY
Bionetic Laboratory Products
Immunology · 116d
Cleared Feb 10, 1984
IM-CHECK
K834345 · KTN
Diagnostic Technology, Inc.
Immunology · 60d
Cleared Feb 10, 1984
TOTAL IGE FAST TEST
K834594 · DGC
Allergenetics
Immunology · 43d
Cleared Feb 10, 1984
LIGHT TEST
K834598 · DHB
Hemogenetics, Inc.
Immunology · 42d
Cleared Feb 10, 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049 · DHR
Diagnostic Products Corp.
Immunology · 35d
Cleared Feb 10, 1984
RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN
K840103 · JHR
Techniclone Intl.
Immunology · 31d
Cleared Feb 04, 1984
SIMPLEX-2
K832541 · GQN
Gentech Australia
Immunology · 190d
Cleared Feb 04, 1984
BHCG-CHECK
K834346 · JHJ
Diagnostic Technology, Inc.
Immunology · 54d
Cleared Feb 03, 1984
LABELED 125I ANTI-IGE
K833419 · DGC
Allergenetics
Immunology · 123d
Cleared Jan 30, 1984
VENTREZYME THEOPHYLLINE IMMUNOASSAY
K833989 · KLS
Vxr, Inc.
Immunology · 73d