The following data is part of a premarket notification filed by Diagnostic Technology, Inc. with the FDA for Hcg-check.
Device ID | K831466 |
510k Number | K831466 |
Device Name: | 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HCG-CHECK 73430025 1283798 Dead/Cancelled |
Diagnostic Technology Inc. 1983-06-13 |
HCG-CHECK 73430024 1290527 Dead/Cancelled |
Diagnostic Technology Inc. 1983-06-13 |