Panels › Clinical Chemistry › Product code CDA · Class 1
Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Regulation 862.1390
0510(k)s in 12 months (3 all time)
1recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in CDA
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 1 | 0 |
| Bio-Rad | 1 | 0 |
| GET TESTED INTERNATIONAL AB | 0 | 1 |
| Immunotech Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 1995 | K952817 | BIO-RAD URINARY 5-HIAA BY HPLC Bio-Rad | CDA |
| Oct 22, 1990 | K903609 | SEROTONIN ENZYME IMMUNOASSAY Immunotech Corp., FR | CDA |
| Jan 17, 1986 | K854946 | TDXR 5-HIAA (URINE) Abbott Laboratories | CDA |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.