TEST, REFORMULATED HYCEL HMA CALCIUM— 510(k) K760468
Substantially EquivalentHycel, Inc.
FDA 510(k) clearance K760468 for TEST, REFORMULATED HYCEL HMA CALCIUM, Substantially Equivalent on 1976-11-01. Applicant: Hycel, Inc.. Device class: 2.
Clearance details
- Applicant
- Hycel, Inc.
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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