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
1825–1848 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 23, 1995
IMMULITE(R) ALLERGY FOOD PANEL FP5E
K943194 · DGO
Diagnostic Products Corp.
Immunology · 233d
Cleared Feb 22, 1995
HEMAGEN ENA SS-B KIT (EIA METHOD)
K946120 · LLL
Hemagen Diagnostics, Inc.
Immunology · 69d
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