HYCEL ROTOR-MIXER AND/OR MULTI
FDA 510(k) clearance K842746 · decided 1984-08-17
Clearance details
- K-number
- K842746
- Device name
- HYCEL ROTOR-MIXER AND/OR MULTI
- Applicant
- R&D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-13
- Decision date
- 1984-08-17
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- KSQ
- Device class
- 1
- Regulation number
- 864.9195
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SEPCOR UNIT COLLECTION MONITOR (K820712) | Separation Science Corp. | 1982-05-07 |
| PLATELET AGITATOR (K812533) | Helmer Labs, Inc. | 1981-09-29 |
| MOBILE MATIC AUTOMATIC DONOR SCALE (K810617) | Lifeline Instruments, Inc. | 1981-04-07 |
| HEMATIC BLOOD MIXER (K802608) | Helmer Labs, Inc. | 1980-12-11 |
| ROYCO MODEL 951 CELL MIXER (K800104) | Royco Instruments | 1980-02-06 |
| PLATELET ROTATOR (K780189) | Travenol Laboratories, S.A. | 1978-03-30 |
| DONORMATIC (BLOOD COLLECTION DEVICE) (K760743) | Lifeline Instruments, Inc. | 1976-12-06 |
Recalls involving this device
No recalls on record reference this clearance.