THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS— 510(k) K123343
Substantially EquivalentMicrogenics Corp.
FDA 510(k) clearance K123343 for THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS, Substantially Equivalent on 2013-07-11. Applicant: Microgenics Corp.. Device class: 2.
Clearance details
- Applicant
- Microgenics Corp.
- Product code
- Code MLM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1678
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont Blvd., CA, US
Recent devices under product code MLM
view allMore clearances from Microgenics Corp.
view allRecalls naming K123343
K-number listed on FDA's recall record- Z-0712-2024 — QMS Tacrolimus Calibrators, Product code 10015573
- Z-1284-2022 — QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123343.
Data sourced from openFDA. This site is unofficial and independent of the FDA.