The following data is part of a premarket notification filed by Diatron Us, Inc. with the FDA for Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron Ise, Diatron Glucose Hexokinase Method.
| Device ID | K151487 |
| 510k Number | K151487 |
| Device Name: | Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method |
| Classification | Hexokinase, Glucose |
| Applicant | Diatron US, Inc. 2304 W 78th Street Hialeah, FL 33016 |
| Contact | Frank Matusazak |
| Correspondent | Erika B Ammirati AMMIRATI REGULATORY CONSULTING 575 SHIRLYNN COURT Los Altos, CA 94022 |
| Product Code | CFR |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-02 |
| Decision Date | 2016-01-14 |
| Summary: | summary |