DBEST ONE STEP OCCULT BLOOD TEST KITS— 510(k) K071242
Substantially EquivalentAmeritek USA, Inc.
FDA 510(k) clearance K071242 for DBEST ONE STEP OCCULT BLOOD TEST KITS, Substantially Equivalent on 2008-03-06. Applicant: Ameritek USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Ameritek USA, Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Everett, WA, US
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