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
1561–1584 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE...
K964010 · MSJ
Beckman Instruments, Inc.
Immunology · 126d
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE...
K964260 · DFH
Beckman Instruments, Inc.
Immunology · 108d
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