STA SYSTEM CONTROL [N] + [P] KIT— 510(k) K943518
Substantially EquivalentAmerican Bioproducts Co.
FDA 510(k) clearance K943518 for STA SYSTEM CONTROL [N] + [P] KIT, Substantially Equivalent on 1995-03-21. Applicant: American Bioproducts Co.. Device class: 2.
Clearance details
- Applicant
- American Bioproducts Co.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parisppany, NJ, US
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More clearances from American Bioproducts Co.
view allRecalls naming K943518
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 K943518.
Data sourced from openFDA. This site is unofficial and independent of the FDA.