AALTO LDH ISOENZYME CONTROL SERUM— 510(k) K820360
Substantially EquivalentAalto Scientific, Ltd.
FDA 510(k) clearance K820360 for AALTO LDH ISOENZYME CONTROL SERUM, Substantially Equivalent on 1982-03-04. Applicant: Aalto Scientific, Ltd.. Device class: 1.
Clearance details
- Applicant
- Aalto Scientific, Ltd.
- Product code
- Code JJT
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.