EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS— 510(k) K922913
Substantially EquivalentSyva Co.
FDA 510(k) clearance K922913 for EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS, Substantially Equivalent on 1992-08-24. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code LBZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code LBZ
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- K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229
Recalls naming K922913
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K922913.
Data sourced from openFDA. This site is unofficial and independent of the FDA.