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
1873–1896 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Apr 21, 1994
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K934594 · DGC
Ciba Corning Diagnostics Corp.
Immunology · 209d
Cleared Apr 21, 1994
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · JZG
Beckman Instruments, Inc.
Immunology · 86d