MOBILE MATIC AUTOMATIC DONOR SCALE
FDA 510(k) clearance K810617 · decided 1981-04-07
Clearance details
- K-number
- K810617
- Device name
- MOBILE MATIC AUTOMATIC DONOR SCALE
- Applicant
- Lifeline Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-03-09
- Decision date
- 1981-04-07
- Days to decision
- 29 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 |
|---|---|---|
| HYCEL ROTOR-MIXER AND/OR MULTI (K842746) | R&D Systems, Inc. | 1984-08-17 |
| SEPCOR UNIT COLLECTION MONITOR (K820712) | Separation Science Corp. | 1982-05-07 |
| PLATELET AGITATOR (K812533) | Helmer Labs, Inc. | 1981-09-29 |
| 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.