EMIT THYROXINE ASSAY— 510(k) K880620
Substantially EquivalentSyva Co.
FDA 510(k) clearance K880620 for EMIT THYROXINE ASSAY, Substantially Equivalent on 1988-03-24. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code KLI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
Recent devices under product code KLI
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- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
Data sourced from openFDA. This site is unofficial and independent of the FDA.