AUTOPHOR 128— 510(k) K810047
Substantially EquivalentGelman Sciences, Inc.
FDA 510(k) clearance K810047 for AUTOPHOR 128, Substantially Equivalent on 1981-02-05. Applicant: Gelman Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Gelman Sciences, Inc.
- Product code
- Code JBD
- Device class
- Class 2
- Regulation
- 21 CFR 864.7440
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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view allData sourced from openFDA. This site is unofficial and independent of the FDA.