Orgentec
Orgentec appears in FDA public data with 0 recalls, 10 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 8, 1996.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | May 8, 1996 |
| K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | May 8, 1996 |
| K954814 | ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY | April 18, 1996 |
| K954815 | ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY | April 18, 1996 |
| K954832 | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY | April 18, 1996 |
| K954829 | ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY | April 18, 1996 |
| K960274 | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY | March 29, 1996 |
| K955133 | ORGENTEC ENASCREEN PIN IMMUNO ASSAY | March 20, 1996 |
| K955134 | ORGENTEC ENASCREEN ELISA ASSAY | March 20, 1996 |
| K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY | November 9, 1995 |