Company ยท US
New England Nuclear
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1984. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDD | Radioassay, Vitamin B12 | 2 |
| CGI | Radioimmunoassay, Estriol | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| CHO | Radioimmunoassay, Cyclic Amp | 1 |
| DID | Bacillus Subtilis Microbiology Assay, Tobramycin | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 1 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JMG | Radioimmunoassay (Two-Site Solid Phase), Ferritin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 14, 1984 | K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY New England Nuclear | CHO |
| Mar 30, 1984 | K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT New England Nuclear | CGI |
| Jan 30, 1984 | K834038 | RIANEN FOLLICLE STIMULATING HORMONE New England Nuclear | CGJ |
| Dec 20, 1983 | K833376 | RIANEN LUTEINIZING HORMONE RIA KIT New England Nuclear | CEP |
| Jun 8, 1983 | K831345 | RIANEN PROLACTIN 125I KIT New England Nuclear | CFT |
| Jun 20, 1980 | K801245 | ATOMLIGHT (LIQUID SCINTILLATION SOLUTION New England Nuclear | JJJ |
| Nov 13, 1979 | K792175 | RIANEN, VITAMIN B12 ASSAY SYSTEM New England Nuclear | CDD |
| May 7, 1979 | K790817 | RIA KIT, QUANTITATION OF PROSTATIC ACID New England Nuclear | JFH |
| Jan 26, 1979 | K782110 | RIA KIT, RIANEN CORTISOL New England Nuclear | CGR |
| Jan 10, 1979 | K781888 | ASSAY SYSTEM, FERRITIN I KIT New England Nuclear | JMG |
| Sep 14, 1978 | K781495 | RIANEN ASSAY SYSTEM, 125I KIT New England Nuclear | DNL |
| Feb 13, 1978 | K780182 | TOBRAMYCIN 125I RIA KIT New England Nuclear | DID |
| Jan 5, 1978 | K772425 | RIANEN GENTAMICIN RIA KIT New England Nuclear | DJB |
| Jan 5, 1978 | K772323 | RIANEN ESTRIOL RIA KIT New England Nuclear | CGI |
| Sep 15, 1977 | K771590 | THYROID STIMULATING HORMONE New England Nuclear | JLW |
| Jan 7, 1977 | K761346 | RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) New England Nuclear | CGR |
| Dec 6, 1976 | K760619 | RADIO IMMUNO ASSAY KIT/ New England Nuclear | CDD |
| Jul 20, 1976 | K760068 | KIT, RIA, GENTAMICIN SULF. New England Nuclear | DJB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||