FDA Device Registration & Listing · Kowloon, HK · Registration 3007838093
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| ILW | Adaptor, Grooming | Physical Medicine | Class 1 | 890.5050 | 2022-07-27 |
| HJY | Reader, Bar, Ophthalmic | Ophthalmic | Class 1 | 886.5800 | 2021-05-18 |
| ITQ | Joint, Knee, External Brace | Physical Medicine | Class 1 | 890.3475 | 2018-04-12 |
| GFE | Brush, Dermabrasion, Powered | General, Plastic Surgery | Class 1 | 878.4820 | 2018-04-12 |
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | Class 1 | 886.5850 | 2022-04-07 |
| LZB | Finger Cot | General Hospital | Class 1 | 880.6250 | 2023-04-21 |
| ITW | Joint, Ankle, External Brace | Physical Medicine | Class 1 | 890.3475 | 2018-04-12 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2023-04-07 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2023-04-07 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2023-04-07 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2023-04-07 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2023-04-07 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2023-04-07 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2023-04-07 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2023-04-07 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2023-04-07 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-04-29 |
| LZA | Polymer Patient Examination Glove | General Hospital | Class 1 | 880.6250 | 2020-04-04 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | Class 2 | 862.1155 | 2019-03-22 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2019-03-22 |
| LYU | Accessory, Surgical Apparel | General, Plastic Surgery | Class 1 | 878.4040 | 2020-05-28 |
| FLL | Continuous Measurement Thermometer | General Hospital | Class 2 | 880.2910 | 2020-06-01 |
| HEB | Tampon, Menstrual, Unscented | Obstetrics/Gynecology | Class 2 | 884.5470 | 2025-03-04 |
| LRR | First Aid Kit With Drug | Unknown | Class N | N/A | 2024-12-23 |
| KCJ | Applicator, Ent | Ear, Nose, Throat | Class 1 | 874.5220 | 2023-05-08 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-04-03 |
| IME | Pack, Hot Or Cold, Reusable | Physical Medicine | Class 1 | 890.5700 | 2011-12-20 |
| HHD | Pad, Menstrual, Unscented | Obstetrics/Gynecology | Class 1 | 884.5435 | 2023-01-17 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2005-12-12 |
| KHA | Mask, Scavenging | Anesthesiology | Class 1 | 868.5590 | 2018-04-12 |
| QUF | Hearing Aid, Air-Conduction, Over The Counter | Ear, Nose, Throat | Class 1 | 874.3300 | 2025-06-17 |
| KGX | Tape And Bandage, Adhesive | General Hospital | Class 1 | 880.5240 | 2026-03-02 |
| EWD | Protector, Hearing (Insert) | Unknown | Class U | N/A | 2022-07-28 |
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | Class 1 | 878.4014 | 2024-12-23 |
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | Class 1 | 890.5710 | 2011-10-07 |
| EFW | Toothbrush, Manual | Dental | Class 1 | 872.6855 | 2005-12-12 |
| SDV | Clinical Electronic Thermometer | General Hospital | Class 2 | 880.2910 | 2025-07-07 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 8043323 | FOURSTAR GROUP INC. | TAIPEI, TW |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K940726 | Jay-Y Enterprises Co., Inc. | NONE-GENERIC | 1994-04-11 |
| K934837 | Simon Marketing, Inc. | SUNGLASSES | 1993-12-08 |
| K852902 | Yours Enterprise Co., Ltd. | METALLIC SUNGLASSES | 1985-08-12 |
| K970895 | Custom Optical Frames, Inc. | CUSTOM OPTICAL SUNGLASS FRAMES | 1997-05-06 |
| K853921 | Winsburn Company , Ltd. | ALL KINDS OF SUNGLASSES | 1985-10-15 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0006-2010 | Biosite Inc | 2 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0007-2010 | Biosite Inc | 2 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0008-2010 | Biosite Inc | 2 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0009-2010 | Biosite Inc | 2 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0010-2010 | Biosite Inc | 2 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3014707731 | NINGBO COOSKIN STATIONERY CO., LTD | Ningbo Zhejiang, CN |
| 3003760853 | Altimate Medical, Inc. | Frankfort, IL, US |
| 3017936791 | JIANGSU PROSPECT HEALTHCARE CO. LTD | Suzhou Jiangsu, CN |
| 3012360263 | YUYAO NEW POWER PROMOTION INDUSTRIAL CO., LTD | Yuyao Zhejiang, CN |
| 3019169621 | INFINITY GOLD INVESTMENT CORP | Tampa, FL, US |
3007838093 when referencing this establishment in official correspondence.