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
1753–1776 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 14, 1995
SERODIA ATG
K953066 · DDC
Fujirebio America, Inc.
Immunology · 45d
Cleared Aug 01, 1995
HUMAN C-REACTIVE PROTEIN KIT (MODIFICATION)
K953207 · DCK
The Binding Site, Ltd.
Immunology · 63d
Cleared Jul 31, 1995
EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP)
K953197 · DCK
Johnson & Johnson Clinical...
Immunology · 21d
Cleared Jul 31, 1995
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR
K953212 · DCK
Randox Laboratories, Ltd.
Immunology · 21d
Cleared Jul 28, 1995
EL-RF/3 (IGM-IGG-IGA) KIT
K941398 · DHR
Theratest Laboratories, Inc.
Immunology · 493d
Cleared Jul 18, 1995
QUANTA LITE(TM) IGG (HRP)
K946034 · MID
Inova Diagnostics, Inc.
Immunology · 221d
Cleared Jul 18, 1995
QUANTA LITE ACA IGM (HRP)
K946385 · MID
Inova Diagnostics, Inc.
Immunology · 221d
Cleared Jul 18, 1995
ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT
K951850 · LJM
Helix Diagnostics, Inc.
Immunology · 88d
Cleared Jul 18, 1995
ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY
K952055 · LRM
American Laboratory Products Co., Ltd.
Immunology · 77d
Cleared Jul 17, 1995
ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT
K951798 · LJM
Helix Diagnostics, Inc.
Immunology · 90d
Cleared Jul 17, 1995
N/T PROTEIN CONTROL SY/L, M AND H
K952593 · DAD
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Jul 17, 1995
N PROTEIN STANDARD SY
K952594 · CZW
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Jul 12, 1995
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI
K942647 · JJY
Scantibodies Laboratory, Inc.
Immunology · 404d
Cleared Jul 05, 1995
UBI MAGIWEL FERRITIN QUANTITATIVE
K951993 · DBF
United Biotech, Inc.
Immunology · 68d
Cleared Jul 05, 1995
OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT
K952425 · JHN
Olympus America, Inc.
Immunology · 42d
Cleared Jun 30, 1995
SPECIFIC IGE ULTRA-EIA
K945884 · DHB
Hycor Biomedical, Inc.
Immunology · 211d
Cleared Jun 30, 1995
DIASTAT ANTI-THYROID PEROXIDASE KIT
K951487 · JZO
Shield Diagnostics, Ltd.
Immunology · 91d
Cleared Jun 30, 1995
DIASTAT ANTI-THYROGLOBULIN KIT
K952183 · JZO
Shield Diagnostics, Ltd.
Immunology · 52d
Cleared Jun 20, 1995
AURAFLEX B2-MICROGLOBULIN
K944846 · JZG
Organon Teknika Corp.
Immunology · 263d
Cleared Jun 20, 1995
ORGENTEC ANTI-TPO ELISA
K952129 · JZO
American Laboratory Products Co., Ltd.
Immunology · 43d
Cleared Jun 20, 1995
ORGENTEC ANTI-TG ELISA
K952130 · JZO
American Laboratory Products Co., Ltd.
Immunology · 43d
Cleared Jun 20, 1995
AMERLITE FERRITIN II ASSAY
K952286 · DBF
Johnson & Johnson Clinical...
Immunology · 35d
Cleared Jun 20, 1995
N LATEX IGA
K952309 · CZP
Behring Diagnostics, Inc.
Immunology · 34d
Cleared Jun 07, 1995
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
K945748 · DHB
Hycor Biomedical, Inc.
Immunology · 196d