The following data is part of a premarket notification filed by Bioscientific with the FDA for Gram Stain Kit.
| Device ID | K781584 |
| 510k Number | K781584 |
| Device Name: | GRAM STAIN KIT |
| Classification | Iodine, Grams |
| Applicant | BIOSCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HYI |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-18 |
| Decision Date | 1978-10-10 |