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
1561–1584 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 10, 1997
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY
K965213 · DDR
Dade Intl., Inc.
Immunology · 42d
Cleared Feb 06, 1997
OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
K963139 · DDD
Olympus America, Inc.
Immunology · 178d
Cleared Feb 06, 1997
TARGET MYOGLOBIN TEST
K963680 · DDR
Texas Immunology, Inc.
Immunology · 143d
Cleared Feb 04, 1997
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
K961024 · KTN
Princeton BioMeditech Corp.
Immunology · 327d
Cleared Feb 04, 1997
CETIBUTEN, 30MCG, SENSI-DISC
K965159 · JTN
Becton Dickinson Microbiology Systems
Immunology · 43d
Cleared Jan 17, 1997
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ
K963695 · JZO
Diagnostic Products Corp.
Immunology · 123d
Cleared Jan 15, 1997
N RHEUMATOLOGY STANDARD SL
K964527 · JIX
Behring Diagnostics, Inc.
Immunology · 64d
Cleared Jan 03, 1997
MICRO21 WITH NDNA
K964165 · DHN
Triangle Biomedical Sciences, Inc.
Immunology · 78d
Cleared Dec 23, 1996
VENTANA CEA PRIMARY ANTIBODY
K940242 · DFD
Ventana Medical Systems, Inc.
Immunology · 1069d
Cleared Dec 23, 1996
PHARMACIA CAP SYSTEM RAST FEIA
K962976 · DHB
Pharmacia & Upjohn Co.
Immunology · 145d
Cleared Dec 18, 1996
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT
K962049 · DCK
Polymedco, Inc.
Immunology · 204d
Cleared Dec 16, 1996
THERATEST EL-RFSCR
K962050 · DHR
Theratest Laboratories, Inc.
Immunology · 202d
Cleared Dec 16, 1996
N LATEX CRP MONO REAGENT
K964687 · DCH
Behring Diagnostics, Inc.
Immunology · 90d
Cleared Dec 13, 1996
N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
K964415 · DHR
Kamiya Technology Services
Immunology · 73d
Cleared Dec 13, 1996
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET
K964418 · DHR
Kamiya Technology Services
Immunology · 73d
Cleared Dec 05, 1996
HEMAGEN ENA DSDNA KIT (EIA METHOD)
K962276 · DHN
Hemagen Diagnostics, Inc.
Immunology · 175d
Cleared Dec 02, 1996
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT
K963170 · DBF
Olympus America, Inc.
Immunology · 110d
Cleared Nov 25, 1996
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015 · DHR
Teco Diagnostics
Immunology · 187d
Cleared Nov 25, 1996
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST
K962019 · DCK
Teco Diagnostics
Immunology · 186d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341 · JNL
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
K962450 · LJM
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451 · JNL
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
K962452 · DBM
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 18, 1996
ORGENTEC ANTI-RNP/SM ELISA
K962057 · LJM
American Laboratory Products Co., Ltd.
Immunology · 174d