B4182-1— 510(k) K820533
Substantially EquivalentAmerican Scientific Products
FDA 510(k) clearance K820533 for B4182-1, Substantially Equivalent on 1982-04-08. Applicant: American Scientific Products. Device class: 2.
Clearance details
- Applicant
- American Scientific Products
- Product code
- Code GIE
- Device class
- Class 2
- Regulation
- 21 CFR 864.5400
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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