Atlas FDA

EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229

FDA 510(k) clearance K011528 · decided 2001-06-06

Clearance details

K-number
K011528
Device name
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
Applicant
Syva Co.
Decision
Substantially Equivalent
Date received
2001-05-17
Decision date
2001-06-06
Days to decision
20 days
Clearance type
Special
Product code
DLZ
Device class
2
Regulation number
862.3660
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
San Jose, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay recall (Z-0181-2014)Siemens Healthcare Diagnostics, Inc.2013-11-07
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019 recall (Z-0664-2013)Siemens Healthcare Diagnostics, Inc.2013-01-10
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019 recall (Z-0030-2013)Siemens Healthcare Diagnostics, Inc.2012-10-10