510(k) K060788 ยท DIF Drug Mixture Control Materials
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
| Applicant | Biosite Incorporated, San Diego CA, US |
| Decision | Substantially Equivalent, Jul 10, 2006 |
| Received | Mar 23, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2019 | QUIDEL CARDIOVASCULAR INC Quidel Triage TOX Drug Screen Control 1
Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box.
Quidel Cardiovascular Inc.
9975 Summers Ridge Road
San Diego, CA 92121 USA
Quidel.com Terminated |
DIF | None listed |
| Oct 23, 2013 | Alere San Diego, Inc. Alere Triage TOX Drug Screen Control 1
Product Generic Name: Quality Control Material
Description of the product:
Good Laboratory Practice suggests that external controls should be tested with each Terminated |
DIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.