New England Nuclear
Mchenry, IL, US
New England Nuclear appears in FDA device records in Mchenry, IL. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for New England Nuclear between 1976 and 1984. The busiest year on record is 1978, with 4. The most recent is 1984, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1978 | 4 |
| 1979 | 4 |
| 1980 | 1 |
| 1983 | 2 |
| 1984 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | CHO | Substantially Equivalent | |
| K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT | CGI | Substantially Equivalent | |
| K834038 | RIANEN FOLLICLE STIMULATING HORMONE | CGJ | Substantially Equivalent | |
| K833376 | RIANEN LUTEINIZING HORMONE RIA KIT | CEP | Substantially Equivalent | |
| K831345 | RIANEN PROLACTIN 125I KIT | CFT | Substantially Equivalent | |
| K801245 | ATOMLIGHT (LIQUID SCINTILLATION SOLUTION | JJJ | Substantially Equivalent | |
| K792175 | RIANEN, VITAMIN B12 ASSAY SYSTEM | CDD | Substantially Equivalent | |
| K790817 | RIA KIT, QUANTITATION OF PROSTATIC ACID | JFH | Substantially Equivalent | |
| K782110 | RIA KIT, RIANEN CORTISOL | CGR | Substantially Equivalent | |
| K781888 | ASSAY SYSTEM, FERRITIN I KIT | JMG | Substantially Equivalent | |
| K781495 | RIANEN ASSAY SYSTEM, 125I KIT | DNL | Substantially Equivalent | |
| K780182 | TOBRAMYCIN 125I RIA KIT | DID | Substantially Equivalent | |
| K772425 | RIANEN GENTAMICIN RIA KIT | DJB | Substantially Equivalent | |
| K772323 | RIANEN ESTRIOL RIA KIT | CGI | Substantially Equivalent | |
| K771590 | THYROID STIMULATING HORMONE | JLW | Substantially Equivalent | |
| K761346 | RADIOIMMUNOASSAY KIT(CORTISOL IN PLASMA) | CGR | Substantially Equivalent | |
| K760619 | RADIO IMMUNO ASSAY KIT/ | CDD | Substantially Equivalent | |
| K760068 | KIT, RIA, GENTAMICIN SULF. | DJB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JFHAcid Phosphatase (Prostatic), Tartrate Inhibited
- DIDBacillus Subtilis Microbiology Assay, Tobramycin
- JJJCounter (Beta, Gamma) For Clinical Use
- CDDRadioassay, Vitamin B12
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- CGRRadioimmunoassay, Cortisol
- CHORadioimmunoassay, Cyclic Amp
- DNLRadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
- CGIRadioimmunoassay, Estriol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- DJBRadioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
