ACRODISC— 510(k) K810829
Substantially EquivalentGelman Sciences, Inc.
FDA 510(k) clearance K810829 for ACRODISC, Substantially Equivalent on 1981-04-08. Applicant: Gelman Sciences, Inc.. Device class: 1.
Clearance details
- Applicant
- Gelman Sciences, Inc.
- Product code
- Code JRL
- Device class
- Class 1
- Regulation
- 21 CFR 862.2050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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