The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Diacrom * Factor X Kit Ha31.
Device ID | K832372 |
510k Number | K832372 |
Device Name: | DIACROM * FACTOR X KIT HA31 |
Classification | Test, Qualitative And Quantitative Factor Deficiency |
Applicant | WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GGP |
CFR Regulation Number | 864.7290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-18 |
Decision Date | 1983-09-29 |