Orgentec
Windham, NH, US
Orgentec appears in FDA device records in Windham, NH. FDA records list 10 510(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
- 10
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Orgentec between 1995 and 1996. The busiest year on record is 1996, with 9. The most recent is 1996, with 9.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1996 | 9 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | LKO | Substantially Equivalent | |
| K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | LKP | Substantially Equivalent | |
| K954832 | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY | LJM | Substantially Equivalent | |
| K954829 | ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY | LJM | Substantially Equivalent | |
| K954815 | ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY | LJM | Substantially Equivalent | |
| K954814 | ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY | LJM | Substantially Equivalent | |
| K960274 | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY | JIR | Substantially Equivalent | |
| K955134 | ORGENTEC ENASCREEN ELISA ASSAY | LLL | Substantially Equivalent | |
| K955133 | ORGENTEC ENASCREEN PIN IMMUNO ASSAY | LLL | Substantially Equivalent | |
| K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY | LRM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LLLExtractable Antinuclear Antibody, Antigen And Control
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain