The following data is part of a premarket notification filed by Alpha-tec Systems, Inc. with the FDA for Ats Gram Stain Control Slide.
| Device ID | K823704 |
| 510k Number | K823704 |
| Device Name: | ATS GRAM STAIN CONTROL SLIDE |
| Classification | Quality Control Slides |
| Applicant | ALPHA-TEC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJG |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-09 |
| Decision Date | 1983-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816085020129 | K823704 | 000 |
| 00816085020112 | K823704 | 000 |
| 00816085020099 | K823704 | 000 |
| 00816085020082 | K823704 | 000 |