VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY— 510(k) K926394
Substantially EquivalentSyva Co.
FDA 510(k) clearance K926394 for VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY, Substantially Equivalent on 1993-05-26. Applicant: Syva Co.. Device class: 1.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code CEP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1485
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code CEP
view allMore clearances from Syva Co.
view all- K011878 — EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL
- K012257 — EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
- K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL
- 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.