EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229— 510(k) K011528

Clearance details

Applicant

Syva Co.

Product code

Code DLZ

Device class

Class 2

Regulation

21 CFR 862.3660

Advisory panel

Clinical Toxicology

Date received

2001-05-17

Decision date

2001-06-06

Decision

Substantially Equivalent

Clearance type

Special

Location

San Jose, CA, US

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• Z-0181-2014 — Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital AssayClass II·Terminated·Siemens Healthcare Diagnostics, Inc.·20130830
• 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.Class II·Terminated·Siemens Healthcare Diagnostics, Inc.·20121210
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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011528.