FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY— 510(k) K884683
Substantially EquivalentSerono-Baker Diagnostics, Inc.
FDA 510(k) clearance K884683 for FERRITIN SEROZYME IMMUNOENZYMETRIC ASSAY, Substantially Equivalent on 1988-12-27. Applicant: Serono-Baker Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Serono-Baker Diagnostics, Inc.
- Product code
- Code DBF
- Device class
- Class 2
- Regulation
- 21 CFR 866.5340
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allentown, PA, US
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More clearances from Serono-Baker Diagnostics, Inc.
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