The following data is part of a premarket notification filed by Scientific Device Laboratory, Inc. with the FDA for Metheno-stain Kit.
| Device ID | K883052 |
| 510k Number | K883052 |
| Device Name: | METHENO-STAIN KIT |
| Classification | Stains, Microbiologic |
| Applicant | SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
| Contact | Lipton, Phd |
| Correspondent | Lipton, Phd SCIENTIFIC DEVICE LABORATORY, INC. 508 ZENITH DR. Glenview, IL 60025 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-19 |
| Decision Date | 1988-08-30 |