FDA Product Code
FDA Product Code KSQ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.9195
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K842746 | HYCEL ROTOR-MIXER AND/OR MULTI | R&D Systems, Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K820712 | SEPCOR UNIT COLLECTION MONITOR | Separation Science Corp. | 1982-05-07 | Traditional | PDF ↗ |
| K812533 | PLATELET AGITATOR | Helmer Labs, Inc. | 1981-09-29 | Traditional | PDF ↗ |
| K810617 | MOBILE MATIC AUTOMATIC DONOR SCALE | Lifeline Instruments, Inc. | 1981-04-07 | Traditional | PDF ↗ |
| K802608 | HEMATIC BLOOD MIXER | Helmer Labs, Inc. | 1980-12-11 | Traditional | PDF ↗ |
| K800104 | ROYCO MODEL 951 CELL MIXER | Royco Instruments | 1980-02-06 | Traditional | PDF ↗ |
| K780189 | PLATELET ROTATOR | Travenol Laboratories, S.A. | 1978-03-30 | Traditional | PDF ↗ |
| K760743 | DONORMATIC (BLOOD COLLECTION DEVICE) | Lifeline Instruments, Inc. | 1976-12-06 | Traditional | PDF ↗ |
Product code KSQ · Class I · Hematology. Data: openFDA.