SUPER-SPIKE TRANSFER SET
FDA 510(k) clearance K802940 · decided 1981-01-15
Clearance details
- K-number
- K802940
- Device name
- SUPER-SPIKE TRANSFER SET
- Applicant
- Geneva Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-19
- Decision date
- 1981-01-15
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- KSB
- Device class
- 2
- Regulation number
- 864.9875
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, 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 |
|---|---|---|
| Kawasumi Laboratories Blood Drawing Kit (BDK) System (K172957) | Kawasumi Laboratories, Inc. | 2018-09-28 |
| KAWASUMI LABORATORY BLOOD DRAWING KIT (K001043) | Kawasumi Laboratories America, Inc. | 2000-05-19 |
| ALPHA PLASMA TRANSFER SET (K820447) | Alpha Therapeutic Corp. | 1982-04-14 |
| FLU-VEN TK-2 (K791130) | Venospital, Inc. | 1979-09-04 |
| FLU VEN TR-1 (K791131) | Venospital, Inc. | 1979-09-04 |
Recalls involving this device
No recalls on record reference this clearance.