VITALAB AMYLASE REAGENT— 510(k) K040534
Substantially EquivalentClinical Data, Inc.
FDA 510(k) clearance K040534 for VITALAB AMYLASE REAGENT, Substantially Equivalent on 2004-03-11. Applicant: Clinical Data, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Data, Inc.
- 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
- Brea, CA, US
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