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
1513–1536 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 23, 1997
UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH
K964152 · DGC
Pharmacia, Inc.
Immunology · 189d
Cleared Apr 22, 1997
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY
K941170 · DEH
Ventana Medical Systems, Inc.
Immunology · 1135d
Cleared Apr 21, 1997
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY
K941707 · DEH
Ventana Medical Systems, Inc.
Immunology · 1111d
Cleared Apr 21, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
K965033 · MGA
Beckman Instruments, Inc.
Immunology · 125d
Cleared Apr 17, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
K965035 · JIQ
Beckman Instruments, Inc.
Immunology · 121d
Cleared Apr 17, 1997
RAICHEM RHEUMATOID FACTOR SPIA
K970373 · DHR
Henage Diagnostics, Inc.
Immunology · 73d
Cleared Apr 16, 1997
BARD AND BTA TEST
K964151 · MMW
Bard Diagnostic Sciences,Inc.
Immunology · 197d
Cleared Apr 10, 1997
MYELOPEROXIDASE ELISA TEST SYSTEM
K964446 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
PROTEINASE-3 IGG ELISA TEST SYSTEM
K964448 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
ANCA SCREEN ELISA TEST SYSTEM
K964449 · MOB
Zeus Scientific, Inc.
Immunology · 155d
Cleared Apr 10, 1997
IMMULITE THYROID AUTOANTIBODY CONTROL MODULE
K971051 · JJX
Diagnostic Products Corp.
Immunology · 17d
Cleared Apr 08, 1997
MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM
K964787 · LLL
Mardx Diagnostics, Inc.
Immunology · 130d
Cleared Apr 08, 1997
IS-ANTI-SSA TEST SYSTEM
K970218 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM TEST SYSTEM
K970220 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-JO-1 TEST SYSTEM
K970228 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SSB TEST SYSTEM (720-260)
K970237 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SM/RNP (720-270)
K970238 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Apr 08, 1997
IS-ANTI-SCL-70 TEST SYSTEM (720-280)
K970239 · LLL
Diamedix Corp.
Immunology · 77d
Cleared Mar 24, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
K964257 · LKL
Beckman Instruments, Inc.
Immunology · 150d
Cleared Mar 19, 1997
IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
K963976 · DDG
Beckman Instruments, Inc.
Immunology · 166d
Cleared Mar 19, 1997
ENZYMUN-TEST PSA
K965085 · LTJ
Boehringer Mannheim Corp.
Immunology · 90d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
K962578 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
K962719 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720 · LLL
Hycor Biomedical, Inc.
Immunology · 249d