ACTIM PROM— 510(k) K123986
Substantially EquivalentAlere Scarborough, Inc.
FDA 510(k) clearance K123986 for ACTIM PROM, Substantially Equivalent on 2014-01-09. Applicant: Alere Scarborough, Inc.. Device class: 1.
Clearance details
- Applicant
- Alere Scarborough, Inc.
- Product code
- Code OAM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1550
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scarborough, ME, US
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Recalls naming K123986
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123986.
Data sourced from openFDA. This site is unofficial and independent of the FDA.