The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Herpes 1 And 2 Microassays.
| Device ID | K871420 |
| 510k Number | K871420 |
| Device Name: | HERPES 1 AND 2 MICROASSAYS |
| Classification | Control, Plasma, Abnormal |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Kiefer, Phd |
| Correspondent | Kiefer, Phd DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-08 |
| Decision Date | 1987-12-11 |