RANDOX PHENYTOIN— 510(k) K011393
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K011393 for RANDOX PHENYTOIN, Substantially Equivalent on 2001-12-04. Applicant: Randox Laboratories, Ltd.. Device class: 2.
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code DIP
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Crumlin, Co. Antrim, IE
Recent devices under product code DIP
view all- K080696 — ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01
- K063145 — PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
- K030428 — ROCHE ONLINE TDM PHENYTOIN
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
- K000006 — IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6
More clearances from Randox Laboratories, Ltd.
view allRecalls naming K011393
K-number listed on FDA's recall record- Z-0929-2014 — ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
- Z-0930-2014 — ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011393.
Data sourced from openFDA. This site is unofficial and independent of the FDA.