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
1441–1464 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Aug 01, 1997
N-ASSAY TIA APO B TEST KIT
K964296 · DER
Crestat Diagnostics, Inc.
Immunology · 276d
Cleared Aug 01, 1997
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE...
K972160 · DCK
Trinity Laboratories, Inc.
Immunology · 53d