This page includes the latest FDA filings for Denka Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3003871639 |
| FEI Number | 3003871639 |
| Name | Sheila W. Pickering |
| Owner & Operator | DENKA CO., LTD. |
| Contact Address | 2-1-1, NIHONBASHI MUROMACHI CHUO-KU JP-13 Tokyo 103-8338 JP |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 2081 Longden Circle Los Altos, CA 94024 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| DENKA COMPANY LIMITED | small dense LDL Control Set 08834105190 | 2020-10-21 |
| DENKA COMPANY LIMITED | small dense LDL Calibrator 08834091190 | 2020-10-21 |
| DENKA COMPANY LIMITED | small dense LDL Seiken 08834075190 | 2020-10-21 |
| DENKA COMPANY LIMITED | small dense LDL Seiken 08834059190 | 2020-10-21 |
Sheila W. Pickering [DENKA CO., LTD.] | BMG Latex X1 & Calibrator Set F | 2018-12-25 |
Sheila W. Pickering [DENKA CO., LTD.] | Urine Protein Control | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | Immuno Q-Sera II | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | Alinity i Insulin Controls | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT Insulin Controls | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT Insulin Calibrators | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | Alinity i Insulin Calibrators | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | Alinity c Rheumatoid Factor Calibrator Kit | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT Insulin Controls | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT Insulin Calibrators | 2018-11-06 |
Sheila W. Pickering [DENKA CO., LTD.] | Lipid Control S-I , Lipid Control S-II | 2018-05-30 |
Sheila W. Pickering [DENKA CO., LTD.] | Lipid Calibrator S | 2018-05-30 |
Sheila W. Pickering [DENKA CO., LTD.] | s LDL-EX "SEIKEN" | 2018-02-28 |
Sheila W. Pickering [DENKA CO., LTD.] | Lipid, ADPN | 2012-05-11 |
Sheila W. Pickering [DENKA CO., LTD.] | VCP ASO/RF PVs & CALI KIT 28 | 2012-03-11 |
Sheila W. Pickering [DENKA CO., LTD.] | VCP RHEUMATOID FACTOR CALIBRATOR KIT 16 | 2012-03-11 |
Sheila W. Pickering [DENKA CO., LTD.] | VCP LIPID CALIBRATOR KIT 19 | 2012-03-11 |
Sheila W. Pickering [DENKA CO., LTD.] | VCP LIPID CALIBRATOR KIT 19 | 2012-03-11 |
Sheila W. Pickering [DENKA CO., LTD.] | VCP LIPID CALIBRATOR KIT 19 | 2012-03-11 |
Sheila W. Pickering [DENKA CO., LTD.] | FERRITIN, ANTIGEN, ANTISERUM, CONTROLCalibrator, secondary | 2012-03-08 |
Sheila W. Pickering [DENKA CO., LTD.] | FERRITIN, ANTIGEN, ANTISERUM, CONTROLCalibrator, secondary | 2012-03-08 |
Sheila W. Pickering [DENKA CO., LTD.] | ALPHA-1 MICROGLOBULIN, ANTIGEN, ANTISERUM, CONTROL | 2012-03-08 |
Sheila W. Pickering [DENKA CO., LTD.] | SYSTEM, TEST, RHEUMATOID FACTOR - Rheumatoid Factor Test Kit | 2011-05-11 |
Sheila W. Pickering [DENKA CO., LTD.] | SYSTEM, TEST, RHEUMATOID FACTOR - Rheumatoid Factor (RF) | 2011-05-11 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT iValproic Acid Assay | 2009-08-24 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT iValproic Acid Assay | 2009-08-24 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHTECT iPhenobarbital | 2008-10-22 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHTECT iPhenobarbital | 2008-10-22 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT iPhenytoin Immunoassay | 2008-09-19 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT iPhenytoin Calibrators (A-F) | 2008-09-19 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT iPhenytoin Immunoassay | 2008-09-19 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT iPhenytoin Calibrators (A-F) | 2008-09-19 |
Sheila W. Pickering [DENKA CO., LTD.] | LDL-EX SEIKEN Assay Kit | 2008-05-07 |
Sheila W. Pickering [DENKA CO., LTD.] | CALIBRATOR, PRIMARY - CRP (II) Calibrators | 2008-05-07 |
Sheila W. Pickering [DENKA CO., LTD.] | C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL - CRP-Latex (II) X2 SEIKEN Assay Kit | 2008-05-07 |
Sheila W. Pickering [DENKA CO., LTD.] | MRSA-Screen | 2008-05-07 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT(R) INSULIN CONTROLS (LOW, MEDIUM AND HIGH) | 2006-03-30 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT(R) INSULIN CALIBRATORS (A-F) | 2006-03-30 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT(R) INSULIN CONTROLS (LOW, MEDIUM AND HIGH) | 2006-03-30 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT(R) INSULIN CALIBRATORS (A-F) | 2006-03-30 |
Sheila W. Pickering [DENKA CO., LTD.] | LP(A)-LATEX SEIKEN ASSAY KIT | 2006-03-30 |
Sheila W. Pickering [DENKA CO., LTD.] | Alinity i Insulin Reagent Kit | 2006-03-30 |
Sheila W. Pickering [DENKA CO., LTD.] | ARCHITECT (R) INSULIN REAGENTS | 2006-03-30 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2018080616572 | Pusan,South Korea -> Seattle, Washington | DENKA SPHERICAL ALUMINA NON-HAZA CHEMICAL HS CODE : 2818.20 | 379 BAG |
| 2018080616571 | Pusan,South Korea -> Seattle, Washington | DENKA SPHERICAL ALUMINA HS CODE : 2818.20 NON-HAZA CHEMICAL | 371 BAG |
| 201808033936 | Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey | PREPARED ADDITIVES FOR CEMENT | 680 BAG |
| 2018080327440 | Pusan,South Korea -> New York/Newark Area, Newark, New Jersey | DENKA ALUMINA FIBER NON-HAZA CHEMICAL HS CODE:6806.10 | 192 CTN |
| 2018080363545 | Tokyo ,Japan -> Long Beach, California | PREPARED ADDITIVES FOR CEMENT NON HAZA CHEMICAL HS CODE: 3824.40 | 200 BAG |
| 2018080235928 | Kobe,Japan -> Los Angeles, California | HTS 2818110 DENKA SPHERICAL ALUMINA | 1 CTN |
| 2018080132354 | Pusan,South Korea -> Tacoma, Washington | DENKA ALUMINA FIBER NON-HAZA CHEMICAL HS CODE:6806.10 | 192 CTN |
| 2018073017284 | Pusan,South Korea -> Seattle, Washington | DENKA SPHERICAL ALUMINA NON-HAZA CHEMICAL HS CODE:2818.20 | 492 BAG |