The following data is part of a premarket notification filed by Burroughs Wellcome Co. with the FDA for Dac-cel Diagnatal.
Device ID | K810214 |
510k Number | K810214 |
Device Name: | DAC-CEL DIAGNATAL |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | BURROUGHS WELLCOME CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-27 |
Decision Date | 1981-03-06 |