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
2353–2376 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 16, 1989
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125 · DGO
Beckman Instruments, Inc.
Immunology · 52d
Cleared Jun 16, 1989
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST
K893737 · KTN
Quidel Corp.
Immunology · 30d
Cleared Jun 13, 1989
LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II
K891680 · JJY
Bio-Rad
Immunology · 84d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-QUANTITATIVE
K892444 · DHR
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 05, 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445 · DHR
Biosearch Medical Products, Inc.
Immunology · 56d
Cleared Jun 02, 1989
ALATOP (TM) CATALOG # AKAL1
K892197 · DGC
Diagnostic Products Corp.
Immunology · 60d
Cleared Jun 02, 1989
ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
K893036 · LRM
Amersham Corp.
Immunology · 39d
Cleared Jun 02, 1989
PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC
K893132 · DHB
Pharmacia, Inc.
Immunology · 38d
Cleared May 17, 1989
NOVA GEL(TM) JO-1
K892897 · LLL
Inova Diagnostics, Inc.
Immunology · 27d
Cleared May 09, 1989
PHADIATOP PAEDIATRIC RIA AND EIA
K891135 · DHB
Pharmacia, Inc.
Immunology · 67d
Cleared May 09, 1989
MONI-TROL(R)
K891929 · JJY
Baxter Healthcare Corp
Immunology · 42d
Cleared May 09, 1989
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · DCK
Technicon Instruments Corp.
Immunology · 36d
Cleared May 09, 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · DBF
Amersham Corp.
Immunology · 33d
Cleared May 09, 1989
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
K892421 · LJM
Lipogen, Inc.
Immunology · 29d
Cleared May 09, 1989
SPQ TM TEST SYSTEM II FOR CRP
K892526 · DCK
Atlantic Antibodies
Immunology · 28d
Cleared May 04, 1989
BEHRING NEPHELOMETER 100
K892223 · JZW
Behring Diagnostics, Inc.
Immunology · 31d
Cleared May 04, 1989
QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN
K892409 · DHB
Quidel Corp.
Immunology · 27d
Cleared Apr 21, 1989
V-TREND TARGET CRP TEST
K892231 · DCN
Texas Immunology, Inc.
Immunology · 17d
Cleared Apr 14, 1989
ANA-5 AUTOANTIBODY PROFILE KIT
K885224 · LKJ
Autoimmunity Diagnostics Corp.
Immunology · 115d
Cleared Apr 14, 1989
EZ COMPLEMENT C1
K891904 · DAC
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
QUIK-DOT C REACTIVE PROTEIN
K892119 · DCK
Ampcor, Inc.
Immunology · 14d
Cleared Apr 14, 1989
EZ COMPLEMENT C2
K892125 · CZW
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
EZ COMPLEMENT C3
K892127 · CZW
Diamedix Corp.
Immunology · 18d
Cleared Apr 14, 1989
EZ COMPLEMENT C4
K892129 · DBI
Diamedix Corp.
Immunology · 18d