Panels › Microbiology › Product code LIR · Class 2
Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
Regulation 866.3390
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LIR
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 1 | 0 |
| Hygeia Sciences | 1 | 0 |
| Thermo Biostar, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2003 | K023947 | GC OIA Thermo Biostar, Inc. | LIR |
| Jul 12, 1988 | K882534 | ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL Abbott Laboratories | LIR |
| Jun 2, 1988 | K881064 | HYGEIA GC TEST Hygeia Sciences | LIR |
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