510(k) K823900
K823900 is an FDA 510(k) premarket notification submitted by Alladin Diagnostic, Inc. for the device "GLUCOSE-6-PHOSPHATE DEHYDROGENASE". The FDA issued a decision of Substantially Equivalent on February 7, 1983. The device falls under product code KQE (Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase), a Class II device regulated under 21 CFR 864.7360. Alladin Diagnostic, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1983
- Date Received
- December 30, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Assay, Erythrocytic Glucose-6-Phosphate Dehydrogenase
- Device Class
- Class II
- Regulation Number
- 864.7360
- Review Panel
- HE
- Submission Type