510(k) K003395 ยท LSL Dna-Reagents, Neisseria
GEN-PROBE APTIMA COMBO 2 ASSAY
| Applicant | Gen-Probe, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, May 21, 2001 |
| Received | Nov 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2014 | Gen-Probe Inc APTIMA Urine Collection Kit; Catalog Number
301040, Lots 27231, 27232, 27233, and 27234.
Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with A Terminated |
OIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.