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
2545–2568 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 22, 1988
QM300 KAPPA LIGHT CHAINS ANTIBODY PACK
K875164 · DFH
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d
Cleared Jan 22, 1988
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK
K875165 · DEH
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 37d
Cleared Jan 21, 1988
MULTICHEM (R) MAGNESIUM REAGENT
K874595 · JGJ
Simmler, Inc.
Immunology · 73d
Cleared Jan 21, 1988
V-TREND BETA-HCG TEST
K874638 · JHJ
Texas Immunology, Inc.
Immunology · 70d
Cleared Jan 11, 1988
IVT SOUTHEAST ALLERGY SCREEN
K874168 · DHB
In Vitro Technologies, Inc.
Immunology · 90d
Cleared Jan 11, 1988
IVT NORTHEAST ALLERGY SCREEN
K874169 · DHB
In Vitro Technologies, Inc.
Immunology · 90d
Cleared Jan 05, 1988
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033 · JHI
Diagnostic Products Corp.
Immunology · 95d
Cleared Dec 30, 1987
MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)
K874446 · DHB
3M Company
Immunology · 63d
Cleared Dec 29, 1987
RF DIPSTICK TEST KIT
K874151 · DHR
Lipogen, Inc.
Immunology · 77d
Cleared Dec 18, 1987
NDNA ANTIBODY TEST KIT
K874191 · LRM
Lipogen, Inc.
Immunology · 65d
Cleared Dec 18, 1987
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
K874281 · DHB
Medix Biotech, Inc.
Immunology · 59d
Cleared Dec 14, 1987
DIFFERENTIAL I.M. SCREENING TEST
K873297 · KTN
Sclavo, Inc.
Immunology · 118d
Cleared Dec 14, 1987
I.M.N. LATEX
K874678 · KTN
Biokit USA, Inc.
Immunology · 31d
Cleared Dec 02, 1987
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM
K874572 · DBF
Nichols Institute Diagnostics
Immunology · 27d
Cleared Nov 27, 1987
REUMA TEST
K873782 · DHR
Sclavo, Inc.
Immunology · 72d
Cleared Nov 25, 1987
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES
K873708 · LLL
Whittaker Bioproducts, Inc.
Immunology · 71d
Cleared Nov 25, 1987
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K874031 · DBF
Diagnostic Products Corp.
Immunology · 54d
Cleared Nov 25, 1987
CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY
K874379 · CZY
Cytotech, Inc.
Immunology · 30d
Cleared Nov 25, 1987
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064
K874406 · DGC
Medix Biotech, Inc.
Immunology · 28d
Cleared Nov 25, 1987
LIVE OAK ALLERGEN DISC
K874440 · DHB
Incstar Corp.
Immunology · 28d
Cleared Nov 04, 1987
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT
K873064 · DHR
Amtec Diagnostics International, Inc.
Immunology · 91d
Cleared Nov 04, 1987
IMMUSTRIP(TM) SM ELISA TEST SYSTEM
K873741 · LKP
Immunomedics, Inc.
Immunology · 49d
Cleared Nov 04, 1987
GIANT RAGWEED ALLERGEN DISC
K873969 · DHB
Incstar Corp.
Immunology · 36d
Cleared Nov 04, 1987
TOTAL IGE FAST (TM) TEST PACKAGE
K873998 · DHB
3M Company
Immunology · 34d