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
1753–1776 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 15, 1995
CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM
K953261 · DHR
Shared Systems, Inc.
Immunology · 34d
Cleared Aug 14, 1995
CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN
K952360 · DDR
Princeton BioMeditech Corp.
Immunology · 103d
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