The following data is part of a De Novo classification by Device Classification Under Section 513(f)(2)(de Novo) // 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 Fo with the FDA for Stabilized Enzyme Solutions.
| DeNovo ID | DK780962 |
| Device Name: | Stabilized Enzyme Solutions |
| Classification | Solution, Stabilized Enzyme |
| Applicant | |
| Contact | Device Classification Under Section 513(f)(2)(de N |
| Product Code | KSK |
| CFR Regulation Number | 864.9400 [🔎] |
| Decision | Substantially Equivalent (SE) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Hematology |
| Classification Advisory | Hematology |
| Type | 510(k) Traditional |
| Date Received | 1978-06-12 |
| Decision Date | 1978-07-27 |
| Reclassification Order: | Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases |