MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229— 510(k) K011161
Substantially EquivalentSyva Co., Dade Behring, Inc.
FDA 510(k) clearance K011161 for MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229, Substantially Equivalent on 2001-05-15. Applicant: Syva Co., Dade Behring, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Syva Co., Dade Behring, Inc.
- Product code
- Code LCM
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Jose, CA, US
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