HEMOCUE HEMOTROL— 510(k) K964052
Substantially EquivalentDirect Solutions
FDA 510(k) clearance K964052 for HEMOCUE HEMOTROL, Substantially Equivalent on 1996-11-06. Applicant: Direct Solutions. Device class: 2.
Clearance details
- Applicant
- Direct Solutions
- Product code
- Code GGM
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westford, MA, US
Recent devices under product code GGM
view allMore clearances from Direct Solutions
view allRecalls naming K964052
K-number listed on FDA's recall record- Z-0514-2019 — 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 verification of the linearity of the HemoCue¿ Hb 201 systems
- Z-0515-2019 — 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 verification of the linearity of the HemoCue¿ Hb 201 systems.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964052.
Data sourced from openFDA. This site is unofficial and independent of the FDA.