510(k) K964052 ยท GGM Control, Hemoglobin
HEMOCUE HEMOTROL
| Applicant | Direct Solutions, Westford MA, US |
| Decision | Substantially Equivalent, Nov 6, 1996 |
| Received | Sep 30, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964052
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2018 | EUROTROL INC HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture
Catalogue number: 171.002.002
Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verificat Terminated |
GGM | None listed |
| Oct 18, 2018 | EUROTROL INC HemoTrol Level 3- In Vitro Diagnostic Hematology quality control mixture.
Catalogue number: 171.003.002
Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verifica Terminated |
GGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.