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
1081–1104 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Dec 06, 1999
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K993304 · DHR
Cogent Diagnotics , Ltd.
Immunology · 63d
Cleared Dec 01, 1999
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56,...
K993388 · DHB
Pharmacia & Upjohn Co.
Immunology · 54d