GLUCOSE HK-60 ASSAY KIT CAT. #201-39— 510(k) K860625
Substantially EquivalentDiagnostic Chemicals, Ltd. (Usa)
FDA 510(k) clearance K860625 for GLUCOSE HK-60 ASSAY KIT CAT. #201-39, Substantially Equivalent on 1986-03-17. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.
Clearance details
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
- Product code
- Code CFR
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroe, CT, US
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