The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Serum Hcg Microassay.
| Device ID | K884430 |
| 510k Number | K884430 |
| Device Name: | SERUM HCG MICROASSAY |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Lin, Phd |
| Correspondent | Lin, Phd DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-21 |
| Decision Date | 1988-12-09 |