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

41 results for "Tosoh Medics, Inc."
1–24 of 41
Search insights Median review: 91d Cleared: 100% Top manufacturer: Tosoh Medics, Inc. Lead specialty: Chemistry
Cleared Dec 18, 2002
ST AIA-PACK CEA ENZYME IMMUNOASSAY
K023893 · DHX
Tosoh Medics, Inc.
Immunology · 26d
Cleared Dec 17, 2002
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · LOJ
Tosoh Medics, Inc.
Immunology · 25d
Cleared Dec 17, 2002
ST AIA-PACK TESTOSTERONE ASSAY
K023091 · CDZ
Tosoh Medics, Inc.
Chemistry · 91d
Cleared Dec 06, 2002
ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
K023891 · LTK
Tosoh Medics, Inc.
Immunology · 14d
Cleared May 14, 2002
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
K020489 · JPD
Tosoh Medics, Inc.
Hematology · 90d
Cleared Dec 14, 2001
AIA-PACK CTNI 2ND-GEN ASSAY
K012820 · MMI
Tosoh Medics, Inc.
Chemistry · 113d
Cleared Sep 18, 2001
G7 AUTOMATED HPLC ANALYZER
K011434 · LCP
Tosoh Medics, Inc.
Hematology · 131d
Cleared Aug 16, 2001
AIA-PACK BRCA, ST AIA PACK BRCA
K010796 · MOI
Tosoh Medics, Inc.
Immunology · 153d
Cleared Aug 10, 1999
AIA-PACK FOLATE ASSAY
K992365 · CGN
Tosoh Medics, Inc.
Chemistry · 26d
Cleared Jun 03, 1999
AIA-PACK CA 125
K990431 · LTK
Tosoh Medics, Inc.
Immunology · 112d
Cleared May 11, 1999
AIA-PACK FT3 ASSAY
K991252 · CDP
Tosoh Medics, Inc.
Chemistry · 28d
Cleared Dec 23, 1998
AIA-PACK TROPONIN I ASSAY
K984359 · MMI
Tosoh Medics, Inc.
Chemistry · 16d
Cleared Oct 08, 1998
AIA-PACK TGAB ASSAY
K981522 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared Oct 08, 1998
AIA-PACK TPOAB ASSAY
K981521 · JZO
Tosoh Medics, Inc.
Immunology · 163d
Cleared May 28, 1998
AIA-PACK MYOGLOBIN ASSAY
K981012 · DDR
Tosoh Medics, Inc.
Immunology · 71d
Cleared Oct 03, 1997
AIA-PACK IGE II ASSAY
K972697 · DGC
Tosoh Medics, Inc.
Immunology · 77d
Cleared Sep 25, 1997
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
K972265 · LCP
Tosoh Medics, Inc.
Hematology · 100d
Cleared Aug 29, 1997
AIA-PACK TSH 3RD-GEN ASSAY
K972586 · JLW
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Jun 27, 1997
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103 · KHO
Tosoh Medics, Inc.
Chemistry · 93d
Cleared Jan 13, 1997
AIA-PACK B12 ASSAY
K964348 · CDD
Tosoh Medics, Inc.
Chemistry · 74d
Cleared Nov 27, 1996
AIA-PACK FOLATE ASSAY
K964349 · CGN
Tosoh Medics, Inc.
Chemistry · 27d
Cleared Nov 08, 1996
AIA-PACK FT3 ASSAY
K963687 · CDP
Tosoh Medics, Inc.
Chemistry · 53d
Cleared Feb 13, 1996
AIA-PACK CPR ASSAY
K951848 · JKD
Tosoh Medics, Inc.
Chemistry · 298d
Cleared Dec 15, 1995
AIA-PACK CORT ASSAY
K954591 · JFT
Tosoh Medics, Inc.
Chemistry · 74d