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
1441–1464 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Oct 03, 1997
CHEMMATE KAPPA
K973391 · DEM
Ventana Medical Systems, Inc.
Immunology · 85d
Cleared Oct 03, 1997
CHEMMATE LAMBDA
K973392 · DEM
Ventana Medical Systems, Inc.
Immunology · 86d
Cleared Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN CONTROL
K973099 · JJX
Dade Chemistry Systems, Inc.
Immunology · 41d
Cleared Sep 29, 1997
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
K973100 · JIT
Dade Chemistry Systems, Inc.
Immunology · 41d
Cleared Sep 29, 1997
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE
K973186 · DHB
Diagnostic Products Corp.
Immunology · 35d
Cleared Sep 29, 1997
RETINOL BINDING PROTEIN RBP RID KIT
K973189 · CZS
The Binding Site, Ltd.
Immunology · 35d
Cleared Sep 25, 1997
WAKO CH50 LINEARITY SET
K973055 · JIW
Wako Chemicals USA, Inc.
Immunology · 41d
Cleared Sep 25, 1997
CHEMMATE LCA
K973393 · DEH
Ventana Medical Systems, Inc.
Immunology · 86d
Cleared Sep 22, 1997
IMMULITE CEA
K970877 · DHX
Diagnostic Products Corp.
Immunology · 196d
Cleared Sep 22, 1997
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972462 · LOJ
Bayer Corp.
Immunology · 83d
Cleared Sep 18, 1997
PROSTATE SPECIFIC ANTIGEN METHOD
K973101 · LTJ
Dade Chemistry Systems, Inc.
Immunology · 30d
Cleared Sep 15, 1997
AXSYM CA 15-3
K963926 · MOI
Abbott Laboratories
Immunology · 350d
Cleared Sep 12, 1997
MODIFICATION OF OPUS FERRITIN TEST SYSTEM
K973202 · DBF
Behring Diagnostics, Inc.
Immunology · 66d
Cleared Sep 09, 1997
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT
K972220 · DHR
Randox Laboratories, Ltd.
Immunology · 89d
Cleared Sep 04, 1997
UNICAP PHADIATOP
K972364 · DHB
Pharmacia, Inc.
Immunology · 71d
Cleared Aug 28, 1997
RAICHEM PREALBUMIN SPIA
K972812 · DDS
Hemagen Diagnostics, Inc.
Immunology · 31d
Cleared Aug 26, 1997
OSOM MONO TEST 143
K972231 · KTN
Wyntek Diagnostics, Inc.
Immunology · 71d
Cleared Aug 22, 1997
IMMULITE 2000 PSA
K972095 · LTJ
Diagnostic Products Corp.
Immunology · 79d
Cleared Aug 20, 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958 · DDG
Beckman Instruments, Inc.
Immunology · 84d
Cleared Aug 12, 1997
PRECICONTROL TUMOR MARKER 1 AND 2
K972235 · JJY
Boehringer Mannheim Corp.
Immunology · 57d
Cleared Aug 08, 1997
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER...
K970695 · MOI
Chiron Diagnostics Corp.
Immunology · 164d
Cleared Aug 04, 1997
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL
K972608 · JJY
Randox Laboratories, Ltd.
Immunology · 54d
Cleared Aug 01, 1997
N-ASSAY TIA APO A1 TEST KIT
K964292 · DER
Crestat Diagnostics, Inc.
Immunology · 276d
Cleared Aug 01, 1997
N-ASSAY TIA APO A1/B MULTI CALIBRATOR
K964294 · DER
Crestat Diagnostics, Inc.
Immunology · 276d