510(k) K883320 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
| Applicant | Sherwood Medical Co., St. Louis MO, US |
| Decision | Substantially Equivalent, Sep 27, 1988 |
| Received | Aug 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883320
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2011 | Covidien LP MONOJECT Blood Collection Tubes containing heparin
13x100 sodium heparin trace element
Item Code 8881307014 Terminated |
JKA | None listed |
| Mar 7, 2011 | Covidien LP MONOJECT Blood Collection Tubes containing heparin
10x50 Sodium Heparin
Item code 8881320157 Terminated |
JKA | None listed |
| Mar 7, 2011 | Covidien LP MONOJECT Blood Collection Tubes containing heparin
10x64 Sodium Heparin
Item code 8881320256 Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.