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
1465–1488 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Jul 30, 1997
TINA-QUANT FERRITIN ASSAY
K964282 · JMG
Boehringer Mannheim Corp.
Immunology · 275d
Cleared Jul 28, 1997
TINAQUANT MYOGLOBIN ASSAY
K972513 · DDR
Boehringer Mannheim Corp.
Immunology · 21d
Cleared Jul 25, 1997
ELECSYS PSA ASSAY
K964351 · LTJ
Boehringer Mannheim Corp.
Immunology · 266d
Cleared Jul 23, 1997
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
K971784 · MID
Zeus Scientific, Inc.
Immunology · 70d
Cleared Jul 14, 1997
N-ASSAY TIA C4 TEST KIT
K964297 · DBI
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964298 · CZW
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964299 · LKL
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964300 · DBI
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA MULTI V-NL
K964301 · DAD
Crestat Diagnostics, Inc.
Immunology · 258d
Cleared Jul 14, 1997
N-ASSAY TIA C1-INACTIVATOR TEST KIT
K965024 · DBA
Crestat Diagnostics, Inc.
Immunology · 209d
Cleared Jul 14, 1997
N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
K965100 · DEM
Crestat Diagnostics, Inc.
Immunology · 206d
Cleared Jul 14, 1997
THYROGLOBULIN ASSAY SYSTEM
K972190 · JZO
American Laboratory Products Co., Ltd.
Immunology · 56d
Cleared Jul 03, 1997
N-ASSAY TIA MULTI CRP CALIBRATOR SET
K965110 · DCK
Crestat Diagnostics, Inc.
Immunology · 195d
Cleared Jul 03, 1997
ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA
K971834 · JNL
Monobind
Immunology · 45d
Cleared Jul 03, 1997
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
K971835 · DDC
Monobind
Immunology · 45d
Cleared Jul 03, 1997
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
K972068 · DHB
Pharmacia, Inc.
Immunology · 30d
Cleared Jun 27, 1997
ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT
K971602 · DHR
Beckman Instruments, Inc.
Immunology · 57d
Cleared Jun 24, 1997
OPUS PSA TEST SYSTEM
K964595 · LTJ
Behring Diagnostics, Inc.
Immunology · 218d
Cleared Jun 24, 1997
QUANTA LITE B2GPI IGG
K970551 · MSV
Inova Diagnostics, Inc.
Immunology · 132d
Cleared Jun 24, 1997
SEALITE SCIENCES, INC. AQUALITE FERRITIN ASSAY
K970612 · DBF
Sealite Sciences, Inc.
Immunology · 126d
Cleared Jun 20, 1997
QUANTA LITE RF IGM
K971614 · DHR
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jun 20, 1997
VIRGO AMA ELISA KIT
K971909 · DBM
Hemagen Diagnostics, Inc.
Immunology · 28d