The following data is part of a premarket notification filed by Electro-nucleonics, Inc. with the FDA for Virgo(r) Microwell Alt Assay.
| Device ID | K884784 |
| 510k Number | K884784 |
| Device Name: | VIRGO(R) MICROWELL ALT ASSAY |
| Classification | Hydrazone Colorimetry, Alt/sgpt |
| Applicant | ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Contact | Karen Darcy |
| Correspondent | Karen Darcy ELECTRO-NUCLEONICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Product Code | CKD |
| CFR Regulation Number | 862.1030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-15 |
| Decision Date | 1988-12-29 |