510(k) K823900
- Device
- GLUCOSE-6-PHOSPHATE DEHYDROGENASE
- Applicant
- ALLADIN DIAGNOSTIC, INC.
- 510(k) number
- K823900
- Product code
- KQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-02-07
- Date received
- 1982-12-30
- Regulation
- 864.7360
- Classification name
- Assay, Erythrocytic Glucose-6-phosphate Dehydrogenase
- Medical specialty
- Hematology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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