Company ยท US
Orgentec
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1996. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 4 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 1996 | K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY Orgentec | LKO |
| May 8, 1996 | K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY Orgentec | LKP |
| Apr 18, 1996 | K954832 | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY Orgentec | LJM |
| Apr 18, 1996 | K954829 | ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY Orgentec | LJM |
| Apr 18, 1996 | K954815 | ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY Orgentec | LJM |
| Apr 18, 1996 | K954814 | ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY Orgentec | LJM |
| Mar 29, 1996 | K960274 | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY Orgentec | JIR |
| Mar 20, 1996 | K955134 | ORGENTEC ENASCREEN ELISA ASSAY Orgentec | LLL |
| Mar 20, 1996 | K955133 | ORGENTEC ENASCREEN PIN IMMUNO ASSAY Orgentec | LLL |
| Nov 9, 1995 | K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY Orgentec | LRM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||