ONLINE TDM Vancomycin Gen.3— 510(k) K152245
Substantially EquivalentRoche Diagnostics Operations (Rdo)
FDA 510(k) clearance K152245 for ONLINE TDM Vancomycin Gen.3, Substantially Equivalent on 2016-01-08. Applicant: Roche Diagnostics Operations (Rdo). Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Operations (Rdo)
- Product code
- Code LEH
- Device class
- Class 2
- Regulation
- 21 CFR 862.3950
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code LEH
view all- K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
- K160202 — Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
- K123947 — ARCHITECT IVANCOMYCIN
- K072036 — ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01
- K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
More clearances from Roche Diagnostics Operations (Rdo)
view allRecalls naming K152245
K-number listed on FDA's recall record- Z-0042-2020 — Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
- Z-0043-2020 — Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152245.
Data sourced from openFDA. This site is unofficial and independent of the FDA.