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
2401–2424 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 24, 1989
ACCESS R-CLONE ANA PROFILE ASSAY
K885048 · DHC
Lipogen, Inc.
Immunology · 48d
Cleared Jan 23, 1989
28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)
K884883 · DHB
Diagnostic Products Corp.
Immunology · 62d
Cleared Jan 23, 1989
V-TREND TARGET IM TEST
K890041 · KTN
Texas Immunology, Inc.
Immunology · 18d
Cleared Jan 11, 1989
MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)
K884923 · DHB
Diagnostic Products Corp.
Immunology · 47d
Cleared Jan 04, 1989
BERICHROM(R) PLASMINOGEN
K884766 · DDX
Behring Diagnostics, Inc.
Immunology · 51d
Cleared Jan 04, 1989
IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)
K885065 · DHB
3M Company
Immunology · 29d
Cleared Jan 04, 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074 · DBF
Bd Becton Dickinson Vacutainer...
Immunology · 27d
Cleared Dec 20, 1988
MODIFICATION OF MONO-PLUS(TM)
K883709 · KTN
Armkel, LLC
Immunology · 112d
Cleared Dec 20, 1988
QM300 PCR ANTIBODY PACK
K885001 · DCN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 19d
Cleared Dec 06, 1988
BECKMAN LAMBDA LIGHT CHAIN REAGENT
K884597 · DFH
Beckman Instruments, Inc.
Immunology · 55d
Cleared Nov 18, 1988
CARDS(TM) MONO
K884007 · KTN
Pacific Biotech, Inc.
Immunology · 58d
Cleared Nov 16, 1988
BECKMAN KAPPA LIGHT CHAIN REAGENT
K884276 · DFH
Beckman Instruments, Inc.
Immunology · 35d
Cleared Nov 16, 1988
RIA/MAT FPA TEST KIT
K884496 · DAN
Altana, Inc.
Immunology · 22d
Cleared Nov 10, 1988
DELFIA (TM) HIGE KIT
K884545 · DGC
Pharmacia, Inc.
Immunology · 10d
Cleared Nov 04, 1988
QM300 CONTROL E
K883537 · DHB
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 78d
Cleared Nov 04, 1988
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217 · LKL
Technicon Instruments Corp.
Immunology · 23d
Cleared Nov 04, 1988
ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)
K884400 · DHN
Immco Diagnostics, Inc.
Immunology · 16d
Cleared Nov 02, 1988
SPQ(TM) TEST SYSTEM FOR PREALBUMIN
K884297 · JZJ
Atlantic Antibodies
Immunology · 21d
Cleared Nov 02, 1988
SPQ(TM) TEST SYSTEM FOR MICROALBUMIN
K884298 · JZJ
Atlantic Antibodies
Immunology · 21d
Cleared Oct 27, 1988
MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10)
K883371 · DHB
3M Company
Immunology · 78d
Cleared Oct 27, 1988
MICROMEDIC FERRITIN IRMA KIT
K883746 · DBF
Icn Micromedic Systems
Immunology · 56d
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2 CELLS)
K883883 · LKJ
Immco Diagnostics, Inc.
Immunology · 44d
Cleared Oct 27, 1988
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · LKJ
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Oct 27, 1988
IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G
K884074 · DAH
Orion Diagnostica, Inc.
Immunology · 30d