510(k) BK140144
- Device
- Stabilized Enzyme Solutions
- Applicant
- ALBA Bioscience Limited (doing Business As Quotient)
- 510(k) number
- BK140144
- Product code
- KSK
- Decision
- Substantially Equivalent (SE)
- Decision date
- 2014-09-17
- Date received
- 2014-07-02
- Regulation
- 864.9400
- Classification name
- Solution, Stabilized Enzyme
- 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 KSK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Gamma Biologicals, Inc. | 1982-03-04 |
| K813404 | FREEZE DRIED FICIN | Biological Corp. of America | 1982-02-10 |
| K810803 | FREEZE DRIED PAPAIN | Biological Corp. of America | 1981-07-21 |
| K780962 | AUTOMATED ENZYME | Hyland Therapeutic Div., Travenol Laboratories | 1978-07-27 |
| K760123 | AUTOZYME | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 |
Legacy Summary#
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FDA Review#
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