The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for B Hcg-check.
Device ID | K831468 |
510k Number | K831468 |
Device Name: | B HCG-CHECK |
Classification | Agglutination Method, Human Chorionic Gonadotropin |
Applicant | DIAGNOSTIC TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHJ |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-06 |
Decision Date | 1983-06-22 |