EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS— 510(k) K913190
Substantially EquivalentSyva Co.
FDA 510(k) clearance K913190 for EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS, Substantially Equivalent on 1991-08-26. Applicant: Syva Co.. Device class: 2.
Clearance details
- Applicant
- Syva Co.
- Product code
- Code DLZ
- Device class
- Class 2
- Regulation
- 21 CFR 862.3660
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
Recent devices under product code DLZ
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
Recalls naming K913190
K-number listed on FDA's recall record- Z-0181-2014 — Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
- Z-0664-2013 — Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma.
- Z-0030-2013 — Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K913190.
Data sourced from openFDA. This site is unofficial and independent of the FDA.