ISOTRAK AMYLASE ISOENZYME CONTROL SET— 510(k) K861329
Substantially EquivalentBehring Diagnostics, Inc.
FDA 510(k) clearance K861329 for ISOTRAK AMYLASE ISOENZYME CONTROL SET, Substantially Equivalent on 1986-04-30. Applicant: Behring Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- Behring Diagnostics, Inc.
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- La Jolla, CA, US
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