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
3505–3528 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 08, 1978
NEPHELRATE ANTISERUMS 1GA
K781655 · CFN
Antibodies, Inc.
Immunology · 42d
Cleared Nov 08, 1978
NEPHELRATE ANTISERUMS, IGG
K781656 · CFN
Antibodies, Inc.
Immunology · 42d
Cleared Oct 17, 1978
STREP-TEX
K781607 · GTZ
Burroughs Wellcome Co.
Immunology · 29d
Cleared Oct 03, 1978
RIA SYSTEM FOR HUMAN FE-RITIN
K781527 · JMG
Calbiochem-Behring Corp.
Immunology · 28d
Cleared Sep 15, 1978
CEA-IMMERSIBLE SEPARATOR
K781043 · JRL
Millipore Corp.
Immunology · 87d
Cleared Sep 14, 1978
RIANEN ASSAY SYSTEM, 125I KIT
K781495 · DNL
New England Nuclear
Immunology · 15d
Cleared Sep 07, 1978
FLUORESCENT ANTI-NATIVE DNA TEST
K780899 · DHN
Kallestad Laboratories, Inc.
Immunology · 97d
Cleared Aug 31, 1978
IMMUNOCHEMISTRY SYS. MANUAL MODE
K781006 · JZW
Beckman Instruments, Inc.
Immunology · 73d
Cleared Aug 31, 1978
DIGOXIN RIA (PEG) KIT
K781335 · DOG
Ortho Diagnostics, Inc.
Immunology · 29d
Cleared Aug 21, 1978
RID SYSTEM-(ACP) TEST
K781408 · DEM
Icl Scientific
Immunology · 7d
Cleared Aug 14, 1978
ANTI-HUMAN LDL SERUM
K781015 · DFC
Icl Scientific
Immunology · 59d
Cleared Aug 14, 1978
C3PA (GBG) PROPERDIN FACTOR B
K781016 · JZH
Icl Scientific
Immunology · 59d
Cleared Aug 14, 1978
ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)
K781017 · DBA
Icl Scientific
Immunology · 59d
Cleared Aug 14, 1978
ANTI-HUMAN CIQ SERUM
K781022 · DAK
Icl Scientific
Immunology · 56d
Cleared Aug 14, 1978
ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU
K781023 · DEX
Icl Scientific
Immunology · 56d
Cleared Aug 14, 1978
CERUOPLASMIN SERUM ANTI-HUMAN
K781024 · DDB
Icl Scientific
Immunology · 56d
Cleared Aug 14, 1978
IMMUNOFLUORESCENCE TEST KIT
K781143
Microbiological Assoc.
Immunology · 35d
Cleared Aug 14, 1978
QUANTIMUNE HTSH IRMA HUMAN THYROID
K781170 · JLW
Bio-Rad
Immunology · 31d
Cleared Aug 14, 1978
IV VITRO GAMMADAB T4 RIA KIT
K781235 · CDX
Clinical Assays, Inc.
Immunology · 26d
Cleared Aug 14, 1978
INSULIN RIA KIT
K781285 · CFP
Serono Laboratories, Inc.
Immunology · 19d
Cleared Aug 10, 1978
ANTITHROMBIN III SERUM, ANTI-HUMAN
K781026 · JBQ
Icl Scientific
Immunology · 52d
Cleared Aug 10, 1978
SECOND ANTIBODY
K781070 · KTS
Pcl-Ria, Inc.
Immunology · 45d
Cleared Jul 27, 1978
LAMBDA SERUM (FREE) ANTI-HUMAN
K781025 · DEH
Icl Scientific
Immunology · 38d
Cleared Jul 27, 1978
KAPPA SERUM (FREE) ANTI-HUMAN
K781027 · DFH
Icl Scientific
Immunology · 38d