Gemsaec Appli. for Ultrazyme Plus CK-1
FDA 510(k) K772034 · Harleco
510(k) numberK772034
Submission
- Device name
- Gemsaec Appli. for Ultrazyme Plus CK-1
- Applicant
- Harleco
Mchenry, IL, US - Received
- October 27, 1977
- Decision date
- November 17, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Harleco
| 510(k) | Device | Decision |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Gemsaec Appli. for Ultrazyme Plus CK-1 cleared by the FDA?
Gemsaec Appli. for Ultrazyme Plus CK-1 (K772034) received a 510(k) decision of Substantially Equivalent on November 17, 1977, 21 days after the submission was received.