RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.— 510(k) K880795
Substantially EquivalentTrace America, Inc.
FDA 510(k) clearance K880795 for RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF., Substantially Equivalent on 1988-04-18. Applicant: Trace America, Inc.. Device class: 2.
Clearance details
- Applicant
- Trace America, Inc.
- Product code
- Code CJE
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.