EMIT TIMER UNIT #100— 510(k) K821531
Substantially EquivalentSyva Co.
FDA 510(k) clearance K821531 for EMIT TIMER UNIT #100, Substantially Equivalent on 1982-06-11. Applicant: Syva Co.. Device class: 1.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code JQP
- Device class
- Class 1
- Regulation
- 21 CFR 862.2100
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JQP
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
Adverse events under product code JQP
product code JQP- Death
- 3
- Malfunction
- 690
- Total
- 693
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.