FETAL BLOOD SAMPLING KIT #1560
FDA 510(k) clearance K831459 · decided 1983-06-30
Clearance details
- K-number
- K831459
- Device name
- FETAL BLOOD SAMPLING KIT #1560
- Applicant
- Transidyne General Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-06
- Decision date
- 1983-06-30
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- HGW
- Device class
- 2
- Regulation number
- 884.1560
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|
| 1570 - FETAL BLOOD SAMPLING KIT (K891388) | Transidyne General Corp. | 1989-03-28 |
| ROCKET FETAL BLOOD SAMPLING TRAY (K884685) | A & A Medical, Inc. | 1989-01-12 |
| FETAL BLOOD SAMPLING KIT MODEL 1560 (K810028) | Transidyne General Corp. | 1981-01-16 |
Recalls involving this device
No recalls on record reference this clearance.