Product code KSQ
- Device name
- Device, Blood Mixing And Blood Weighing
- Medical specialty
- Hematology
- Device class
- 1
- Regulation number
- 864.9195
- 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 |
|---|---|---|---|
| K842746 | HYCEL ROTOR-MIXER AND/OR MULTI | R&D Systems, Inc. | 1984-08-17 |
| K820712 | SEPCOR UNIT COLLECTION MONITOR | Separation Science Corp. | 1982-05-07 |
| K812533 | PLATELET AGITATOR | Helmer Labs, Inc. | 1981-09-29 |
| K810617 | MOBILE MATIC AUTOMATIC DONOR SCALE | Lifeline Instruments, Inc. | 1981-04-07 |
| K802608 | HEMATIC BLOOD MIXER | Helmer Labs, Inc. | 1980-12-11 |
| K800104 | ROYCO MODEL 951 CELL MIXER | Royco Instruments | 1980-02-06 |
| K780189 | PLATELET ROTATOR | Travenol Laboratories, S.A. | 1978-03-30 |
| K760743 | DONORMATIC (BLOOD COLLECTION DEVICE) | Lifeline Instruments, Inc. | 1976-12-06 |
Related GUDID Devices#
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|---|---|---|---|
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| 04086000860895 | COMPOGUARD Advance Data | Fresenius Kabi AG | 2024-10-29 |
| 04086000860901 | COMPOGUARD Advance COMPLETE | Fresenius Kabi AG | 2024-10-29 |
| 00850047037077 | HemoFlow | Applied Science, Inc. | 2024-03-11 |
| 00850047037084 | HemoFlow | Applied Science, Inc. | 2024-03-11 |
| 00850047037053 | HemoFlow | Applied Science, Inc. | 2023-09-08 |
| 00863626000270 | Boekel Blood Collection Mixer | BOEKEL INDUSTRIES, INC. | 2023-06-08 |
| 00850047037022 | HemoFlow | Applied Science, Inc. | 2023-03-14 |
| 00850047037046 | HemoFlow | Applied Science, Inc. | 2023-03-03 |
| 00850047037039 | HemoFlow | Applied Science, Inc. | 2023-03-03 |
| 00850047037008 | HemoFlow | Applied Science, Inc. | 2023-02-21 |
| 00850047037015 | HemoFlow | Applied Science, Inc. | 2023-02-21 |
| 04038917141154 | Tube- Stripper AST-2 | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04038917258869 | Tube-Stripper AST-2S | Sarstedt Aktiengesellschaft & Co.KG | 2022-11-30 |
| 04086000860741 | CompoGuard Basic (NA) | Fresenius Kabi AG | 2022-11-10 |
| 04086000860758 | CompoGuard Data (NA) | Fresenius Kabi AG | 2022-11-10 |
| 04086000860765 | CompoGuard Complete (NA) | Fresenius Kabi AG | 2022-11-10 |
| 00810020440065 | Donor Tube Stripper | Fresenius Kabi AG | 2022-11-04 |
| 00810020440348 | Fresenius Kabi Adjustable Automatic Donor Scale Support Stand | Fresenius Kabi AG | 2021-08-18 |
| 10810020440345 | Fresenius Kabi Adjustable Automatic Donor Scale Support Stand | Fresenius Kabi AG | 2021-08-18 |
| 04028339620139 | TRANSWAAG | Transmed Medizintechnik GmbH & Co. KG | 2020-09-01 |
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| 00863626000218 | Boekel Small Platelet Agitator | BOEKEL INDUSTRIES, INC. | 2019-05-16 |
| 00816394020988 | Helmer | HELMER, INC. | 2019-02-08 |
| 00816394020971 | Helmer | HELMER, INC. | 2019-02-08 |
| 00816394020995 | Helmer | HELMER, INC. | 2019-02-08 |
| 00863626000225 | Boekel Large Platelet Agitator | BOEKEL INDUSTRIES, INC. | 2017-01-31 |