The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Enzymatic Co2 Diagnostic Chemical.
| Device ID | K841664 |
| 510k Number | K841664 |
| Device Name: | ENZYMATIC CO2 DIAGNOSTIC CHEMICAL |
| Classification | Enzymatic, Carbon-dioxide |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KHS |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-23 |
| Decision Date | 1984-06-08 |