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
2401–2424 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 07, 1989
ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS
K885269 · DHB
Dexall Biomedical Labs, Inc.
Immunology · 47d
Cleared Feb 03, 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K884180 · DHR
Unipath , Ltd.
Immunology · 126d
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