Panels › Immunology › Product code CZN · Class 2
Iga, Fitc, Antigen, Antiserum, Control
Regulation 866.5510
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in CZN
| Company | 510(k)s | Recalls |
|---|---|---|
| Gelco Diagnostics, Inc. | 2 | 0 |
| Dako Corp. | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| Intl. Diagnostic Technology | 1 | 0 |
| Kallestad Laboratories, Inc. | 1 | 0 |
| Miles Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 12, 1989 | K891683 | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER Helena Laboratories | CZN |
| Feb 26, 1986 | K855011 | QUANTIMETRIC PLUS C3 REAGENT KIT Kallestad Laboratories, Inc. | CZN |
| Jun 1, 1984 | K841815 | OPTIMATE IGA TEST Miles Laboratories, Inc. | CZN |
| Oct 31, 1983 | K832262 | FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS Gelco Diagnostics, Inc. | CZN |
| Oct 28, 1983 | K832257 | GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC Gelco Diagnostics, Inc. | CZN |
| Jul 18, 1983 | K831909 | RABBIT ANTISERUM TO HUMAN IGA Dako Corp. | CZN |
| Jun 22, 1983 | K831607 | FIAX IGA TEST KIT Intl. Diagnostic Technology | CZN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.