510(k) BK930021
- Device
- Blood Bank Supplies
- Applicant
- MIGADAS INC
- 510(k) number
- BK930021
- Product code
- KSS
- Decision
- Substantially Equivalent (SE)
- Decision date
- 1993-11-16
- Date received
- 1993-07-07
- Regulation
- 864.9050
- Classification name
- Supplies, Blood-bank
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Clearance type
- 510(k) Traditio
- Third party reviewed
- No
Other 510(k) Records For Product Code KSS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874436 | FLUID SAMPLING PACK | U.S. Mfg. & Management, Inc. | 1988-01-05 |
| K812892 | S/P SERUM DROPPER PIPETS | American Dade | 1981-10-27 |
| K801386 | PRE-DENT SYSTEM OR PRE-DENT II | Pre-Dent System | 1980-07-14 |
| K801516 | PRE-DENT SYSTEM MODIFIED | Pre-Dent System | 1980-07-14 |
| K800736 | PRE-DENT SYSTEM | Pre-Dent System | 1980-04-24 |
| K761303 | IMMU-SAL IMMUNOHEMATOLOGICAL SALINE | Dade, Baxter Travenol Diagnostics, Inc. | 1976-12-30 |
Legacy Summary#
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FDA Review#
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