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
1849–1872 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 12, 1994
I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS
K945522 · DFT
Beckman-Diagnostic Systems Group
Immunology · 32d
Cleared Dec 02, 1994
ANTI DS-DNA
K943291 · LLL
Sigma Diagnostics, Inc.
Immunology · 147d
Cleared Dec 02, 1994
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E
K944486 · JJY
International Enzymes, Inc.
Immunology · 80d
Cleared Dec 02, 1994
LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E
K944513 · JJY
International Enzymes, Inc.
Immunology · 78d
Cleared Nov 21, 1994
DAKO MOUSE ANTI-HUMAN T-CELL
K924804 · DEH
Dako Corp.
Immunology · 788d
Cleared Nov 21, 1994
DIASTAT ENA SINGLE WELL SCREEN KIT
K944505 · LLL
Shield Diagnostics, Ltd.
Immunology · 68d
Cleared Oct 25, 1994
QUANTA LITE ENA 5 ELISA KIT
K943076 · LLL
Inova Diagnostics, Inc.
Immunology · 119d
Cleared Oct 20, 1994
N LATEX RF
K942328 · DHR
Behring Diagnostics, Inc.
Immunology · 168d
Cleared Oct 13, 1994
APHLELISA KIT
K933588 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 444d
Cleared Oct 03, 1994
BEHRING NEPHELOMETER II
K943997 · DEW
Behring Diagnostics, Inc.
Immunology · 48d
Cleared Oct 03, 1994
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
K944288 · DCK
Hemagen Diagnostics, Inc.
Immunology · 31d
Cleared Oct 03, 1994
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · DCK
Behring Diagnostics, Inc.
Immunology · 26d
Cleared Sep 26, 1994
ANTI-RETICULIN ANTIBODY (ARA) TEST
K913360 · DBL
Immco Diagnostics, Inc.
Immunology · 1155d
Cleared Sep 26, 1994
IGM RHEUMATOID FACTOR
K942272 · DHR
Immco Diagnostics, Inc.
Immunology · 139d
Cleared Sep 20, 1994
ELIAS CARDIOLIPIN ANTIBODIES
K940403 · MID
Elias U.S.A., Inc.
Immunology · 236d
Cleared Sep 09, 1994
PLASMINOGEN RID TEST KIT
K941346 · DDX
The Binding Site, Ltd.
Immunology · 172d
Cleared Sep 09, 1994
TNT TROPONIN T
K942632 · JJX
Streck Laboratories, Inc.
Immunology · 98d
Cleared Sep 07, 1994
VENTANA EMA PRIMARY ANDIBODY
K940243 · DHF
Ventana Medical Systems, Inc.
Immunology · 231d
Cleared Sep 07, 1994
HUMAN IGG SUBCLASSES ELISA COMBI KIT
K943098 · DAS
Research Diagnostics, Inc.
Immunology · 71d
Cleared Sep 07, 1994
HUMAN IGG SUBCLASSES RID COMBI KIT (MODIFICATION)
K943205 · DAS
Research Diagnostics, Inc.
Immunology · 64d
Cleared Aug 26, 1994
ACCESS RED BLOOD CELL FOLATE ASSAY
K943149 · CGN
Beckman Coulter, Inc.
Immunology · 57d
Cleared Jul 28, 1994
ANA SCREEN ELISA TEST SYSTEM
K940362 · LLL
Zeus Scientific, Inc.
Immunology · 183d
Cleared Jul 18, 1994
THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY
K936010 · DDC
Biomerica, Inc.
Immunology · 214d
Cleared Jun 30, 1994
RADIAS ANA SCREEN ENZYME IMMUNOASSAY
K941509 · LJM
Bio-Rad
Immunology · 93d