510(k) K834208 ยท JJM Osmometer For Clinical Use
COLLOID OSMOMETER 4400
| Applicant | Wescor, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 23, 1984 |
| Received | Dec 5, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K834208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2008 | Wescor, Inc Osmocoll, COP Calibrator/Osmolality Control, SS-025, 6 unit packages- 1 mL vials (Normal), Manufactured for Wescor, Inc., 459 South Main Street, Logan, Utah 84321. Terminated |
JJM | None listed |
| Mar 27, 2008 | Wescor, Inc Osmocoll, COP Control Reference, SS-038, Contents: 6 unit packages of 1 mL vials (3 each High and Low), Wescor, Inc., 459 South Main Street, Logan, Utah 84321. Terminated |
JJM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.