The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for N-assay Glu-ul.
| Device ID | K980883 |
| 510k Number | K980883 |
| Device Name: | N-ASSAY GLU-UL |
| Classification | Hexokinase, Glucose |
| Applicant | CRESTAT DIAGNOSTICS, INC. 910 INDUSTRY DR. Seattle, WA 98056 |
| Contact | Colin Getty |
| Correspondent | Colin Getty CRESTAT DIAGNOSTICS, INC. 910 INDUSTRY DR. Seattle, WA 98056 |
| Product Code | CFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-09 |
| Decision Date | 1998-09-03 |
| Summary: | summary |