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
3289–3312 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 03, 1981
THREE LEVEL CONTROL SERA
K810459 · DHX
Bd Becton Dickinson Vacutainer...
Immunology · 164d
Cleared Jul 23, 1981
PHADEBAS IGG RAST TEST
K810694 · DEW
Pharmacia, Inc.
Immunology · 129d
Cleared Jul 21, 1981
FREEZE DRIED PAPAIN
K810803 · KSK
Biological Corp. of America
Immunology · 119d
Cleared Jul 16, 1981
KALLESTAD'S ENDOPLATE FACTOR B TEST
K811740 · JZH
Kallestad Laboratories, Inc.
Immunology · 27d
Cleared Jul 16, 1981
LEECO FERRITIN-QUANT DIAG. TEST KIT
K811880 · DBF
Leeco Diagnostics, Inc.
Immunology · 15d
Cleared Jul 10, 1981
LIGHTNING DIALYZER
K810871 · DHY
Clintox Laboratories, Inc.
Immunology · 101d
Cleared Jul 10, 1981
MRI PROLACTIN RIA KIT
K810949 · CFT
Microanalytic Research, Inc.
Immunology · 94d
Cleared Jul 10, 1981
HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT
K811714 · DHN
Scripps-Miles, Inc.
Immunology · 23d
Cleared Jul 02, 1981
HELENA PLASMINOGEN QUIPLATE PROCEDURE
K811777 · DDX
Helena Laboratories
Immunology · 9d
Cleared Jun 25, 1981
QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.
K811617 · DCK
Kallestad Laboratories, Inc.
Immunology · 17d
Cleared Jun 24, 1981
KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
K811445 · DHL
Kallestad Laboratories, Inc.
Immunology · 33d
Cleared Jun 16, 1981
SCRIPPSERA COMPLEMENT CONTROL SERA
K811433 · DHL
Scripps-Miles, Inc.
Immunology · 25d
Cleared May 29, 1981
TOX TM ANALYZER
K811263 · JQZ
Abbott Laboratories
Immunology · 23d
Cleared May 08, 1981
AIM SYSTEM (FOR IGM)
K811124 · DFT
Icl Scientific
Immunology · 14d
Cleared May 08, 1981
AIM SYSTEM (FOR IGA)
K811125 · CZP
Icl Scientific
Immunology · 14d
Cleared May 08, 1981
AIM SYSTEM (FOR IGG)
K811126 · DEW
Icl Scientific
Immunology · 14d
Cleared May 05, 1981
RUBAZYME - M
K810835 · GOK
Abbott Laboratories
Immunology · 41d
Cleared May 05, 1981
DIRECT IMMUNOFLUOR. ANTIBODY TEST KIT
K810856 · GPT
Bartels Immunodiagnostic Supplies, Inc.
Immunology · 36d
Cleared May 01, 1981
ANTITHYROID ANTIBODY IMMUNOFLUORESCENT
K810982 · JZO
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTISMOOTH MUSCLE ANTIBODY TEST SYS
K810983 · DBE
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTIMITOCHONDRIAL IMMUNOFLUORESCENT TEST
K810984 · DBM
Immuno-Products Industries
Immunology · 18d
Cleared May 01, 1981
ANTINUCLEAR ANTIBODY IMMUNOFLUORESCENT
K810985 · DHN
Immuno-Products Industries
Immunology · 18d
Cleared Apr 29, 1981
ANTI NDNA IMMUNOFLOURESCENT TEST SYS
K810981 · DHC
Immuno-Products Industries
Immunology · 16d
Cleared Apr 23, 1981
BCD-HPP41C INTERFACE
K810968 · JQP
Dynatech Corp.
Immunology · 14d