NORMAL UNASSAYED CONTROL SERA— 510(k) K780351
Substantially EquivalentMacomb Chemical Co.
FDA 510(k) clearance K780351 for NORMAL UNASSAYED CONTROL SERA, Substantially Equivalent on 1978-04-24. Applicant: Macomb Chemical Co.. Device class: 1.
Clearance details
- Applicant
- Macomb Chemical Co.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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