The following data is part of a premarket notification filed by Accra Laboratories, Inc. with the FDA for Gram Stain Set W/stabilized Iodine.
| Device ID | K843429 |
| 510k Number | K843429 |
| Device Name: | GRAM STAIN SET W/STABILIZED IODINE |
| Classification | Stains, Microbiologic |
| Applicant | ACCRA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-04 |
| Decision Date | 1984-09-14 |