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
1873–1896 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 30, 1994
HEMAGEN ACL IGA CALIBRATOR
K941840 · MID
Hemagen Diagnostics, Inc.
Immunology · 78d
Cleared Jun 21, 1994
AXSYM FERRITIN
K935847 · DBF
Abbott Laboratories
Immunology · 195d
Cleared Jun 16, 1994
N/T PROTEIN CONTROL SY/L, M, AND H
K941912 · JJY
Behring Diagnostics, Inc.
Immunology · 58d
Cleared Jun 13, 1994
DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
K924726 · DEH
Dako Corp.
Immunology · 630d
Cleared Jun 13, 1994
DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)
K932136 · DEH
Dako Corp.
Immunology · 406d
Cleared Jun 10, 1994
SELISA ANTI-N DNA ANTIBODIES
K940585 · LRM
Cambridge Life Sciences Plc.
Immunology · 122d
Cleared Jun 10, 1994
AUTOZYME SCREEN
K940700 · LJM
Cambridge Life Sciences Plc.
Immunology · 114d
Cleared Jun 10, 1994
ENA SCREEN ELISA TEST SYSTEM
K941014 · LJM
Zeus Scientific, Inc.
Immunology · 99d
Cleared Jun 10, 1994
ENA PROFILE-6 ELISA TEST SYSTEM
K941409 · LJM
Zeus Scientific, Inc.
Immunology · 79d
Cleared Jun 02, 1994
ENA EIA TEST KIT
K935413 · LLL
David A. Fuccillo, Ph.D.
Immunology · 205d
Cleared May 27, 1994
IGG SUBCLASS SINGLE DILUTION DIAGNOSTIC KIT FOR USE WITH THE BECKMAN ARRAY...
K940422 · DFZ
The Binding Site, Ltd.
Immunology · 128d
Cleared May 17, 1994
HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
K940183 · DGC
Hycor Biomedical, Inc.
Immunology · 125d
Cleared May 11, 1994
SYN ENA SCREEN (PIN PLATE)
K940229 · LLL
Elias U.S.A., Inc.
Immunology · 113d
Cleared May 11, 1994
ELIAS ENA SCREEN (MICROTITER PLATE)
K940622 · LLL
Elias U.S.A., Inc.
Immunology · 113d
Cleared May 11, 1994
THYROGLOBULIN EIA TEST KIT
K941358 · JNL
Immunoprobe, Inc.
Immunology · 51d
Cleared May 11, 1994
MICROSOMAL EIA TEST KIT
K941361 · JNL
Immunoprobe, Inc.
Immunology · 51d
Cleared May 05, 1994
JO-1 EIA TEST KIT
K935417 · LLL
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared May 05, 1994
SCL-70 EIA TEST KIT
K935418 · LLL
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared May 05, 1994
LA EIA TEST KIT
K935419 · LLL
David A. Fuccillo, Ph.D.
Immunology · 177d
Cleared May 03, 1994
MITOCHONDRIA EIA TEST KIT
K940251 · DBM
David A. Fuccillo, Ph.D.
Immunology · 104d
Cleared May 02, 1994
SM EIA TEST KIT
K935414 · LJM
David A. Fuccillo, Ph.D.
Immunology · 174d
Cleared May 02, 1994
RNP EIA TEST KIT
K935415 · LJM
David A. Fuccillo, Ph.D.
Immunology · 174d
Cleared May 02, 1994
RO EIA TEST KIT
K935416 · LJM
David A. Fuccillo, Ph.D.
Immunology · 174d
Cleared May 02, 1994
HISTONE EIA TEST KIT
K940253 · LJM
David A. Fuccillo, Ph.D.
Immunology · 103d