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 |