ROCKET FETAL BLOOD SAMPLING TRAY
FDA 510(k) clearance K884685 · decided 1989-01-12
Clearance details
- K-number
- K884685
- Device name
- ROCKET FETAL BLOOD SAMPLING TRAY
- Applicant
- A & A Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-08
- Decision date
- 1989-01-12
- Days to decision
- 65 days
- Clearance type
- Traditional
- Product code
- HGW
- Device class
- 2
- Regulation number
- 884.1560
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Branford, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch A & A Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| FETAL BLOOD SAMPLING KIT #1560 (K831459) | Transidyne General Corp. | 1983-06-30 |
| FETAL BLOOD SAMPLING KIT MODEL 1560 (K810028) | Transidyne General Corp. | 1981-01-16 |
Recalls involving this device
No recalls on record reference this clearance.