PARAMAX(R) PHENYTOIN REAGENT— 510(k) K932686
Substantially EquivalentBaxter Diagnostics, Inc.
FDA 510(k) clearance K932686 for PARAMAX(R) PHENYTOIN REAGENT, Substantially Equivalent on 1993-11-26. Applicant: Baxter Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Baxter Diagnostics, Inc.
- 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
- Irvine, CA, US
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
- K011393 — RANDOX PHENYTOIN
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
More clearances from Baxter Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.