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
1633–1656 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 10, 1996
QUANTA LITE ENA 6 ELISA
K961913 · LLL
Inova Diagnostics, Inc.
Immunology · 54d
Cleared Jul 10, 1996
N LATEX CRP MONO REAGENT
K962523 · DCK
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Jul 05, 1996
DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
K951965 · DEH
Dako Corp.
Immunology · 435d
Cleared Jul 02, 1996
CHEMMATE(TM) CD43
K950148 · DEH
Biotek Solutions, Inc.
Immunology · 532d
Cleared Jun 26, 1996
RHEUMATOID FACTOR LATEX SLIDE TEST KIT
K961169 · DHR
Randox Laboratories, Ltd.
Immunology · 93d
Cleared Jun 20, 1996
THYROID PEROXIDASE ANTIBODY ELISA
K960369 · JZO
Immco Diagnostics, Inc.
Immunology · 147d
Cleared Jun 20, 1996
THYROGLOBULIN ANTIBODY ELISA
K960370 · JZO
Immco Diagnostics, Inc.
Immunology · 147d
Cleared Jun 14, 1996
COMPLEMENT CONTROL
K960874 · JJX
Wako Chemicals USA, Inc.
Immunology · 102d
Cleared Jun 04, 1996
LIQUICHEK RHEUMATOID FACTOR CONTROL
K960987 · DHR
Bio-Rad
Immunology · 85d
Cleared May 30, 1996
VENTANNA ANTI-CD3 PRIMARY ANTIBODY
K941505 · DEH
Ventana Medical Systems, Inc.
Immunology · 793d
Cleared May 30, 1996
DIASTAT ANTI-CARDIOLIPIN KIT
K955303 · MID
Shield Diagnostics, Ltd.
Immunology · 192d
Cleared May 23, 1996
RIBOSOMAL P EIA TEST SYSTEM
K950169 · MQA
Hogan & Hartson
Immunology · 492d
Cleared May 23, 1996
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
K955449 · MID
American Laboratory Products Co., Ltd.
Immunology · 176d
Cleared May 08, 1996
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY
K954830 · LKP
Orgentec
Immunology · 201d
Cleared May 08, 1996
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY
K954831 · LKO
Orgentec
Immunology · 201d
Cleared May 08, 1996
RF IGM ELISA TEST SYSTEM
K961277 · DHR
Zeus Scientific, Inc.
Immunology · 35d
Cleared Apr 23, 1996
RIT LIVER, KIDNEY, STOMACH IFA KIT
K955431 · DBL
The Binding Site, Ltd.
Immunology · 147d
Cleared Apr 19, 1996
RELSIA SCL-70 ANTIBODY TEST SYSTEM
K955602 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM
K955603 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELISA SM/RNP ANTIBODY TEST SYSTEM
K955604 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
RELISA JO-1 ANTIBODY TEST SYSTEM
K955605 · LLL
Immuno Concepts, Inc.
Immunology · 133d
Cleared Apr 19, 1996
CRP-LATEX SEIKEN XR REAGENT SYSTEM
K960702 · DCK
Globe Management Support, Inc.
Immunology · 59d
Cleared Apr 19, 1996
RF-LATEX SEIKEN REAGENT SYSTEM
K960703 · DHR
Globe Management Support, Inc.
Immunology · 59d
Cleared Apr 18, 1996
ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY
K954814 · LJM
Orgentec
Immunology · 182d