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
3481–3504 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 15, 1979
PROACTIVATOR C3, C4 AND C3
K790059 · KTP
Icl Scientific
Immunology · 65d
Cleared Mar 15, 1979
IIF-A-N-DNA TEST KIT
K790106 · DHC
Medica Corp.
Immunology · 56d
Cleared Mar 15, 1979
ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI
K790252 · DHN
Meloy Laboratories, Inc.
Immunology · 37d
Cleared Mar 15, 1979
SYSTEMIC LUPUS
K790257 · DHC
Icl Scientific
Immunology · 37d
Cleared Mar 15, 1979
CALBIOCHEM-BEHRING LASER IMMUNOGLOBULIN
K790330 · JJY
Calbiochem-Behring Corp.
Immunology · 27d
Cleared Mar 15, 1979
RHEUMATELL
K790351 · DHR
Central Biological Co.
Immunology · 21d
Cleared Mar 15, 1979
TRYPTIC SOY AGAR W/ 5% HORSE BLOOD
K790375 · JSG
Granite Diagnostics, Inc.
Immunology · 20d
Cleared Mar 12, 1979
LUPO-TEC
K782129 · DHC
Armkel, LLC
Immunology · 75d
Cleared Mar 02, 1979
SPINSEP-FE59
K790133 · JQG
Nuclear Diagnostics, Inc.
Immunology · 38d
Cleared Feb 26, 1979
I TESTOTERONE
K790007 · CDZ
Cambridge Nuclear Corp.
Immunology · 55d
Cleared Feb 26, 1979
I ESTRIOL
K790008 · CGI
Cambridge Nuclear Corp.
Immunology · 55d
Cleared Feb 16, 1979
ANTISERA, RHODAMINE CONJUGATED FRAGMENT
K781951 · DCE
Kallestad Laboratories, Inc.
Immunology · 87d
Cleared Feb 15, 1979
FLUROMETER, DADE
K782150 · JZT
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 51d
Cleared Feb 08, 1979
RIA KIT, QUANTITOPE IGE
K781904 · DGC
Kallestad Laboratories, Inc.
Immunology · 87d
Cleared Jan 26, 1979
RHEUMOGEN TEST SYSTEM
K790012 · DHR
Calbiochem-Behring Corp.
Immunology · 24d
Cleared Jan 17, 1979
TEST KIT, IIF-ANA
K782048 · DHN
Medica Corp.
Immunology · 40d
Cleared Jan 10, 1979
RIA TEST, NORDICALB HPL
K782099 · JMF
Nordiclab Intl.
Immunology · 23d
Cleared Jan 03, 1979
FIAX TEST KIT
K782041 · DHN
Idt, A Division of Whittaker M.A....
Immunology · 27d
Cleared Dec 29, 1978
BETA-TEC
K781794 · JHI
Wampole Laboratories
Immunology · 65d
Cleared Dec 20, 1978
RUBINDEX*DIRECT SYSTEM
K781638 · GOK
Ortho Diagnostics, Inc.
Immunology · 90d
Cleared Dec 20, 1978
RIA KIT, PREG-STAT
K781733 · JHI
Serono Laboratories, Inc.
Immunology · 68d
Cleared Nov 15, 1978
PLASMINOGEN ASSAY
K781478 · DDX
Dade, Baxter Travenol Diagnostics, Inc.
Immunology · 79d
Cleared Nov 08, 1978
NEPHELRATE ANTISERUMS C3C
K781653 · CZW
Antibodies, Inc.
Immunology · 42d
Cleared Nov 08, 1978
NEPHELRATE ANTIPERUMS LGM
K781654 · CFN
Antibodies, Inc.
Immunology · 42d