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
1609–1632 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 25, 1996
QUANTEX IGA
K962200 · CZP
Instrumentation Laboratory CO
Immunology · 110d
Cleared Sep 25, 1996
QUANTEX IGM
K962201 · DFT
Instrumentation Laboratory CO
Immunology · 110d
Cleared Sep 24, 1996
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
K961544 · DGR
Consolidated Technologies, Inc.
Immunology · 155d
Cleared Sep 24, 1996
QUALITROL RF CONTROLS
K961545 · DHR
Consolidated Technologies, Inc.
Immunology · 155d
Cleared Sep 24, 1996
QUALITROL MONO CONTROL SERUM SET
K961550 · KTN
Consolidated Technologies, Inc.
Immunology · 155d
Cleared Sep 13, 1996
LIQUITROL-TM, TUMOR MARKER CONTROL, LEVEL 1 AND 2
K961359 · JJY
Bioprocessing, Inc.
Immunology · 157d
Cleared Sep 13, 1996
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM
K963275 · LLL
Immuno Concepts, Inc.
Immunology · 24d
Cleared Sep 12, 1996
UNICAP 100
K962274 · DHB
Pharmacia, Inc.
Immunology · 91d
Cleared Sep 12, 1996
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)
K962836 · DHR
Hemagen Diagnostics, Inc.
Immunology · 52d
Cleared Sep 10, 1996
VENTANA ANTI-CD5 PRIMARY ANTIBODY
K941782 · DEH
Ventana Medical Systems, Inc.
Immunology · 883d
Cleared Sep 09, 1996
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY
K962469 · MID
American Laboratory Products Co., Ltd.
Immunology · 76d
Cleared Sep 05, 1996
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
K962499 · JZT
Bartels, Inc.
Immunology · 71d
Cleared Aug 29, 1996
PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM)
K962975 · JJX
Diagnostic Products Corp.
Immunology · 29d
Cleared Aug 19, 1996
PR-3 ELISA TEST SYSTEM
K961764 · MOB
Immunoprobe, Inc.
Immunology · 104d
Cleared Aug 19, 1996
MPO ELISA TEST SYSTEM
K961765 · MOB
Immunoprobe, Inc.
Immunology · 104d
Cleared Aug 19, 1996
QUALITROL CRP CONTROL SET
K961829 · DCK
Consolidated Technologies, Inc.
Immunology · 98d
Cleared Aug 15, 1996
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET
K961912 · JJY
Consolidated Technologies, Inc.
Immunology · 90d
Cleared Aug 15, 1996
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K962344 · DDR
Bayer Corp.
Immunology · 58d
Cleared Aug 15, 1996
OPUS MYOGLOBIN CONTROLS
K962841 · JJX
Behring Diagnostics, Inc.
Immunology · 24d
Cleared Aug 01, 1996
N ANTISERUM TO C1 INHIBITOR
K960257 · DBA
Behring Diagnostics, Inc.
Immunology · 196d
Cleared Jul 23, 1996
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
K961824 · DCF
Roche Diagnostic Systems, Inc.
Immunology · 74d
Cleared Jul 12, 1996
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
K960669 · CFF
Morax
Immunology · 143d
Cleared Jul 11, 1996
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
K962373 · DCK
Behring Diagnostics, Inc.
Immunology · 21d
Cleared Jul 10, 1996
NOVA LITE ANCA
K961340 · MOB
Inova Diagnostics, Inc.
Immunology · 107d