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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Kamiya Biomedical Co."
1–24 of 43
Search insights Median review: 48d Cleared: 100% Top manufacturer: Kamiya Biomedical Co. Lead specialty: Immunology
Cleared Sep 28, 2010
K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL
K093137 · NDY
Kamiya Biomedical Co.
Chemistry · 358d
Cleared Apr 29, 2010
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR
K091486 · DCF
Kamiya Biomedical Co.
Chemistry · 345d
Cleared Dec 23, 2005
K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET
K050944 · DBF
Kamiya Biomedical Co.
Immunology · 253d
Cleared Dec 10, 2004
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
K042241 · DGC
Kamiya Biomedical Co.
Immunology · 113d
Cleared Jun 27, 2003
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090
K030687 · DAP
Kamiya Biomedical Co.
Hematology · 114d
Cleared Feb 04, 2003
K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP...
K023828 · DCK
Kamiya Biomedical Co.
Immunology · 78d
Cleared Dec 13, 2002
K-ASSAY LP(A) CONTROLS
K023853 · DFC
Kamiya Biomedical Co.
Immunology · 24d
Cleared Aug 14, 2002
K-ASSAY HS-CRP CONTROLS
K022486 · DCK
Kamiya Biomedical Co.
Immunology · 16d
Cleared Jul 25, 2002
K-ASSAY LP(A) ASSAY
K021660 · DFC
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Feb 19, 2002
K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
K014293 · DBF
Kamiya Biomedical Co.
Immunology · 53d
Cleared Aug 21, 2001
K-ASSAY D-DIMER CONTROLS
K012422 · GGC
Kamiya Biomedical Co.
Hematology · 22d
Cleared Jul 25, 2001
K-ASSAY C1-INA
K011780 · DBA
Kamiya Biomedical Co.
Immunology · 48d
Cleared May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · DAP
Kamiya Biomedical Co.
Hematology · 239d
Cleared May 16, 2001
K-ASSAY HS-CRP CONTROLS
K011079 · DCK
Kamiya Biomedical Co.
Immunology · 37d
Cleared Oct 25, 2000
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558 · DCK
Kamiya Biomedical Co.
Immunology · 72d
Cleared Apr 26, 2000
K-ASSAY AT-III
K000361 · JBQ
Kamiya Biomedical Co.
Hematology · 82d
Cleared Dec 27, 1999
K-ASSAY MULTI-ANALYTE CALIBRATOR
K993853 · JIX
Kamiya Biomedical Co.
Chemistry · 45d
Cleared Dec 06, 1999
K-ASSAY FIBRINOGEN
K993482 · GIS
Kamiya Biomedical Co.
Hematology · 53d
Cleared Nov 30, 1999
K-ASSAY TRANSFERRIN
K993537 · DDG
Kamiya Biomedical Co.
Immunology · 42d
Cleared Nov 30, 1999
K-ASSAY IGM
K993323 · CFF
Kamiya Biomedical Co.
Immunology · 57d
Cleared Nov 29, 1999
K-ASSAY C4
K993481 · DBI
Kamiya Biomedical Co.
Immunology · 46d
Cleared Nov 26, 1999
K-ASSAY APO A1/B CALIBRATOR SET
K993606 · JIX
Kamiya Biomedical Co.
Chemistry · 32d
Cleared Nov 24, 1999
K-ASSAY HAPTOGLOBIN
K993480 · DAD
Kamiya Biomedical Co.
Immunology · 41d
Cleared Nov 24, 1999
K-ASSAY ALPHA-1 AT
K993444 · DEM
Kamiya Biomedical Co.
Immunology · 43d