Electro-Nucleonics, Inc.
Medical device manufacturer in Columbia, MD.
9510(k) clearances
0PMA approvals
0recalls
Device types
- GQO Antisera, Cf, Herpesvirus Hominis 1,2 2
- CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- CKD Hydrazone Colorimetry, Alt/Sgpt 1
- GQI Antiserum, Cf, Cytomegalovirus 1
- GQX Antiserum, Cf, Varicella-Zoster 1
- GNP Antiserum, Cf, Epstein-Barr Virus 1
- CET Olive Oil Emulsion (Turbidimetric), Lipase 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K893718 | Deltatest (R) Lipase IICET · Traditional | 09/28/1989SE |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional | 04/28/1989SE |
| K883427 | Virgo(R) Vzv-Igg ElisaGQX · Traditional | 03/10/1989SE |
| K883282 | Virgo HSV-1 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883281 | Virgo HSV-2 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883102 | Virgo (R) Cmv-Igg ElisaGQI · Traditional | 02/08/1989SE |
| K884784 | Virgo(R) Microwell Alt AssayCKD · Traditional | 12/29/1988SE |
| K883206 | Lactate Dehydrogenase LDHCFJ · Traditional | 09/09/1988SE |
| K883205 | Altlts Alanine Amino Transferase AltCKA · Traditional | 09/09/1988SE |