The following data is part of a premarket notification filed by American Scientific Products with the FDA for Stool-collection/preservation Kit.
| Device ID | K822870 |
| 510k Number | K822870 |
| Device Name: | STOOL-COLLECTION/PRESERVATION KIT |
| Classification | Container, Specimen Mailer And Storage, Sterile |
| Applicant | AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDT |
| CFR Regulation Number | 864.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-09-27 |
| Decision Date | 1982-11-01 |