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
1081–1104 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 01, 2000
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
K994148 · JQC
Implant Innovations, Inc.
Immunology · 55d
Cleared Jan 18, 2000
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993928 · DEW
Wako Chemicals USA, Inc.
Immunology · 61d
Cleared Jan 18, 2000
RHIGENE ANA ELISA TEST SYSTEM
K994071 · LJM
Rhigene, Inc.
Immunology · 47d
Cleared Jan 18, 2000
ACCESS HYBRITECH PSA QC, MODEL 37209
K994200 · JJX
Beckman Coulter, Inc.
Immunology · 36d
Cleared Jan 14, 2000
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
K993924 · CFN
Wako Chemicals USA, Inc.
Immunology · 57d
Cleared Jan 14, 2000
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
K993927 · CZP
Wako Chemicals USA, Inc.
Immunology · 57d
Cleared Jan 12, 2000
ENA PROFILE ELISA TEST SYSTEM
K993839 · LLL
Trinity Biotech USA
Immunology · 61d
Cleared Jan 11, 2000
MDI RF TEST
K993843 · DHR
Micro Detect, Inc.
Immunology · 60d
Cleared Jan 11, 2000
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B...
K993971 · LLL
Micro Detect, Inc.
Immunology · 49d
Cleared Jan 11, 2000
MDI SM TEST
K994029 · LLL
Micro Detect, Inc.
Immunology · 46d
Cleared Jan 10, 2000
MDI SM/RNP TEST
K993635 · LJM
Micro Detect, Inc.
Immunology · 75d
Cleared Jan 10, 2000
MDI SS-A TEST
K993636 · LJM
Micro Detect, Inc.
Immunology · 75d
Cleared Jan 05, 2000
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
K993210 · JJX
Beckman Coulter, Inc.
Immunology · 103d
Cleared Jan 05, 2000
VARELISA TPO ANTIBODIES, MODEL 12348/12396
K993585 · JZO
Pharmacia & Upjohn Co.
Immunology · 75d
Cleared Dec 21, 1999
IGM MININEPH ANTISERUM
K981784 · CFN
The Binding Site, Ltd.
Immunology · 580d
Cleared Dec 21, 1999
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
K993612 · MVM
The Binding Site, Ltd.
Immunology · 57d
Cleared Dec 21, 1999
BINDAZYME ANTI-DSDNA EIA KIT
K993727 · LRM
The Binding Site, Ltd.
Immunology · 57d
Cleared Dec 20, 1999
C3 MININEPH ANTISERUM
K981783 · CZW
The Binding Site, Ltd.
Immunology · 579d
Cleared Dec 20, 1999
C4 MININEPH ANTISERUM
K981785 · DBI
The Binding Site, Ltd.
Immunology · 579d
Cleared Dec 20, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
K981915 · JJY
The Binding Site, Ltd.
Immunology · 567d
Cleared Dec 20, 1999
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
K982100 · CFN
The Binding Site, Ltd.
Immunology · 553d
Cleared Dec 09, 1999
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
K992939 · JJY
Seracare Technology
Immunology · 100d
Cleared Dec 09, 1999
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
K993631 · JJY
Seracare Technology
Immunology · 43d
Cleared Dec 06, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY,...
K992188 · JNM
Nichols Institute Diagnostics
Immunology · 160d