SODIUM BICARBONATE (7.5%) SOLUTION— 510(k) K810780
Substantially EquivalentDutchland Laboratories, Inc.
FDA 510(k) clearance K810780 for SODIUM BICARBONATE (7.5%) SOLUTION, Substantially Equivalent on 1981-05-13. Applicant: Dutchland Laboratories, Inc.. Device class: 1.
Clearance details
- Applicant
- Dutchland Laboratories, Inc.
- Product code
- Code KIT
- Device class
- Class 1
- Regulation
- 21 CFR 864.2220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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