RAPET RF— 510(k) K974370
Substantially EquivalentStanbio Laboratory
FDA 510(k) clearance K974370 for RAPET RF, Substantially Equivalent on 1998-02-17. Applicant: Stanbio Laboratory. Device class: 2.
Clearance details
- Applicant
- Stanbio Laboratory
- Product code
- Code DHR
- Device class
- Class 2
- Regulation
- 21 CFR 866.5775
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
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Recalls naming K974370
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 K974370.
Data sourced from openFDA. This site is unofficial and independent of the FDA.