Product code KSS
- Device name
- Supplies, Blood-Bank
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.9050
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874436 | FLUID SAMPLING PACK | U.S. Mfg. & Management, Inc. | 1988-01-05 |
| K812892 | S/P SERUM DROPPER PIPETS | American Dade | 1981-10-27 |
| K801386 | PRE-DENT SYSTEM OR PRE-DENT II | Pre-Dent System | 1980-07-14 |
| K801516 | PRE-DENT SYSTEM MODIFIED | Pre-Dent System | 1980-07-14 |
| K800736 | PRE-DENT SYSTEM | Pre-Dent System | 1980-04-24 |
| K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07540151300121 | RadTag | Radtag Technologies Inc | 2025-12-30 |
| 07540151300138 | RadTag | Radtag Technologies Inc | 2025-12-30 |
| 07540151300145 | RadTag | Radtag Technologies Inc | 2025-12-30 |
| 07540151300152 | RadTag | Radtag Technologies Inc | 2025-12-30 |
| 05060242472596 | ORTHO® Elution Kit | ALBA BIOSCIENCE LIMITED | 2025-12-04 |
| 19555240405613 | SampLok® Sampling Kit 16mL | ITL ASIA PACIFIC SDN. BHD. | 2025-06-04 |
| 07540151300107 | AccuTag | Radtag Technologies Inc | 2023-11-02 |
| 05060242477959 | ALBA Elution Kit | ALBA BIOSCIENCE LIMITED | 2023-10-13 |
| 00810106410340 | Rad-Sure™ | ASHLAND SPECIALTY INGREDIENTS G.P. | 2023-05-10 |
| 00810106410333 | Rad-Sure™ | ASHLAND SPECIALTY INGREDIENTS G.P. | 2023-05-10 |
| 00810106410326 | Rad-Sure™ | ASHLAND SPECIALTY INGREDIENTS G.P. | 2023-04-24 |
| 07540151300046 | RadTag | Radtag Technologies Inc | 2022-12-02 |
| 07540151300053 | RadTag | Radtag Technologies Inc | 2022-12-02 |
| 07540151300060 | RadTag | Radtag Technologies Inc | 2022-12-02 |
| 07540151300077 | RadTag | Radtag Technologies Inc | 2022-12-02 |
| 07540151300039 | RadTag | Radtag Technologies Inc | 2022-12-01 |
| 07540151300008 | RadTag | Radtag Technologies Inc | 2022-12-01 |
| 07540151300015 | RadTag | Radtag Technologies Inc | 2022-12-01 |
| 07540151300022 | RadTag | Radtag Technologies Inc | 2022-12-01 |
| 00812269031295 | Typesafe | TYPENEX MEDICAL LLC | 2022-11-21 |
| 20812269031275 | Typesafe | TYPENEX MEDICAL LLC | 2022-11-21 |
| 00812269031264 | Typesafe 2.0 | TYPENEX MEDICAL LLC | 2022-11-21 |
| 00812269031240 | Typesafe 2.0 | TYPENEX MEDICAL LLC | 2022-11-21 |
| 20810020440533 | Hematype Segment Device | Fresenius Kabi AG | 2022-11-08 |
| 19555240401349 | Segment Sampler (SEG) | ITL ASIA PACIFIC SDN. BHD. | 2020-09-19 |
| 10758750006090 | MTS | MICRO TYPING SYSTEMS, INC | 2018-12-21 |
| 10758750006069 | MTS | MICRO TYPING SYSTEMS, INC | 2018-12-21 |
| 10758750006052 | MTS | MICRO TYPING SYSTEMS, INC | 2018-12-21 |
| 10758750006113 | MTS | MICRO TYPING SYSTEMS, INC | 2016-08-24 |
| 10758750006106 | MTS | MICRO TYPING SYSTEMS, INC | 2016-08-24 |