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
1513–1536 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
K964762 · DDB
Beckman Instruments, Inc.
Immunology · 149d
Cleared Apr 25, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)
K964766 · DEM
Beckman Instruments, Inc.
Immunology · 149d
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