On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis— 510(k) K170587
Substantially EquivalentACON Laboratories, Inc.
FDA 510(k) clearance K170587 for On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis, Substantially Equivalent on 2017-07-06. Applicant: ACON Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- ACON Laboratories, Inc.
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.