The following data is part of a premarket notification filed by Scientific Device Laboratory, Inc. with the FDA for Acid Fast Bacilli Stain Control.
| Device ID | K840515 |
| 510k Number | K840515 |
| Device Name: | ACID FAST BACILLI STAIN CONTROL |
| Classification | Quality Control Slides |
| Applicant | SCIENTIFIC DEVICE LABORATORY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LJG |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-06 |
| Decision Date | 1984-03-09 |