The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Dac-cel Diagnatal Hcg Standards Rd49.
| Device ID | K830204 |
| 510k Number | K830204 |
| Device Name: | DAC-CEL DIAGNATAL HCG STANDARDS RD49 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-20 |
| Decision Date | 1983-02-18 |