The following data is part of a premarket notification filed by Diatron Group with the FDA for Diatron Pictus 400.
| Device ID | K101741 |
| 510k Number | K101741 |
| Device Name: | DIATRON PICTUS 400 |
| Classification | Glucose Oxidase, Glucose |
| Applicant | DIATRON GROUP 2545 MONTCLAIRE CIRCLE Westo, FL 33327 |
| Contact | Jim Schepp |
| Correspondent | Jim Schepp DIATRON GROUP 2545 MONTCLAIRE CIRCLE Westo, FL 33327 |
| Product Code | CGA |
| 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 | 2010-06-22 |
| Decision Date | 2011-01-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05999883586891 | K101741 | 000 |
| 15999883586881 | K101741 | 000 |
| 15999883586706 | K101741 | 000 |
| 05999883586693 | K101741 | 000 |
| 15999883586683 | K101741 | 000 |
| 15999860094231 | K101741 | 000 |
| 15999860094224 | K101741 | 000 |
| 15999860094187 | K101741 | 000 |