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
1825–1848 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 22, 1995
HEMAGEN ENA SS-A KIT (EIA METHOD)
K946121 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K946122 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA SM KIT (EIA METHOD)
K946123 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 22, 1995
HEMAGEN ENA JO-1 KIT (EIA METHOD)
K946124 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2
K946048 · JZG
Clinical Controls, Inc.
Immunology · 60d
Cleared Feb 10, 1995
LIQUISPEX(TM) LIQUID CRP CONTROL LEVEL 1 AND 2
K946050 · DCK
Clinical Controls, Inc.
Immunology · 60d
Cleared Feb 10, 1995
FERRITIN CONTROL - LEVEL 1, 2, 3
K946266 · DGD
Clinical Controls, Inc.
Immunology · 49d
Cleared Feb 07, 1995
LIFESIGN MI MYOGLOBIN
K942052 · DDR
Princeton Biomedix
Immunology · 285d
Cleared Jan 24, 1995
VARELISA M2 ANTIBODIES
K945607 · DBM
Elias U.S.A., Inc.
Immunology · 70d
Cleared Jan 20, 1995
SPECIFIC IGE EIA-ULTRA ASSAY
K941057 · DHB
Hycor Biomedical, Inc.
Immunology · 318d
Cleared Jan 20, 1995
IGM RF EIA
K942908 · DHR
Sigma Diagnostics, Inc.
Immunology · 213d
Cleared Jan 20, 1995
ANTI-HISTONE ANIBODY TEST
K943585 · LJM
Immco Diagnostics, Inc.
Immunology · 182d
Cleared Dec 22, 1994
AUTOSTAT II ANTI-THYROGLOBULIN
K943625 · DDC
Cogent Diagnotics , Ltd.
Immunology · 149d
Cleared Dec 22, 1994
VARELISA RNP-SM ANTIBODIES
K944167 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA LA (SS-B) ANTIBODIES
K944168 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA RO (SS-A) ANTIBODIES
K944169 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SM ANTIBODIES
K944170 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA CENTROMERE ANTIBODIES
K944171 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA SCL-70 ANTIBODIES
K944172 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 22, 1994
VARELISA JO-1 ANTIBODIES
K944173 · LJM
Elias U.S.A., Inc.
Immunology · 118d
Cleared Dec 19, 1994
IMMULITE ALATOP ALLERGY SCREEN
K941564 · DHB
Diagnostic Products Corp.
Immunology · 262d
Cleared Dec 15, 1994
HUMAN IGG SUBCLASSES NEPHELOMETRIC BNA KIT
K944876 · DAS
Research Diagnostics, Inc.
Immunology · 73d
Cleared Dec 12, 1994
I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS
K945522 · DFT
Beckman-Diagnostic Systems Group
Immunology · 32d
Cleared Dec 02, 1994
ANTI DS-DNA
K943291 · LLL
Sigma Diagnostics, Inc.
Immunology · 147d