Company ยท US
Electro-Nucleonics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1989. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 2 |
| CET | Olive Oil Emulsion (Turbidimetric), Lipase | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| CKD | Hydrazone Colorimetry, Alt/Sgpt | 1 |
| GNP | Antiserum, Cf, Epstein-Barr Virus | 1 |
| GQI | Antiserum, Cf, Cytomegalovirus | 1 |
| GQX | Antiserum, Cf, Varicella-Zoster | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 28, 1989 | K893718 | DELTATEST (R) LIPASE II Electro-Nucleonics, Inc. | CET |
| Apr 28, 1989 | K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI Electro-Nucleonics, Inc. | GNP |
| Mar 10, 1989 | K883427 | VIRGO(R) VZV-IGG ELISA Electro-Nucleonics, Inc. | GQX |
| Mar 10, 1989 | K883282 | VIRGO HSV-1 IGG ELISA Electro-Nucleonics, Inc. | GQO |
| Mar 10, 1989 | K883281 | VIRGO HSV-2 IGG ELISA Electro-Nucleonics, Inc. | GQO |
| Feb 8, 1989 | K883102 | VIRGO (R) CMV-IGG ELISA Electro-Nucleonics, Inc. | GQI |
| Dec 29, 1988 | K884784 | VIRGO(R) MICROWELL ALT ASSAY Electro-Nucleonics, Inc. | CKD |
| Sep 9, 1988 | K883206 | LACTATE DEHYDROGENASE LDH Electro-Nucleonics, Inc. | CFJ |
| Sep 9, 1988 | K883205 | ALTLTS ALANINE AMINO TRANSFERASE ALT Electro-Nucleonics, Inc. | CKA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||