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
1609–1632 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
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