The following data is part of a premarket notification filed by American Scientific Products with the FDA for Bio-check Gram Stain Control.
| Device ID | K821660 |
| 510k Number | K821660 |
| Device Name: | BIO-CHECK GRAM STAIN CONTROL |
| Classification | Kit, Quality Control For Culture Media |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTR |
| CFR Regulation Number | 866.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-04 |
| Decision Date | 1982-06-25 |