AMYLASE REAGENT SET (KINETIC)— 510(k) K931080
Substantially EquivalentTeco Diagnostics
FDA 510(k) clearance K931080 for AMYLASE REAGENT SET (KINETIC), Substantially Equivalent on 1993-11-05. Applicant: Teco Diagnostics. Device class: 2.
Clearance details
- Applicant
- Teco Diagnostics
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Placentia, CA, US
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More clearances from Teco Diagnostics
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