The following data is part of a premarket notification filed by Texas Immunology, Inc. with the FDA for Count-10 Trol.
| Device ID | K822540 |
| 510k Number | K822540 |
| Device Name: | COUNT-10 TROL |
| Classification | Urinalysis Controls (assayed And Unassayed) |
| Applicant | TEXAS IMMUNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJW |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-23 |
| Decision Date | 1982-10-08 |