UNICAP GLIADIN IGG ASSAY— 510(k) K982701
Substantially EquivalentPharmacia & Upjohn Co.
FDA 510(k) clearance K982701 for UNICAP GLIADIN IGG ASSAY, Substantially Equivalent on 1998-10-22. Applicant: Pharmacia & Upjohn Co.. Device class: 2.
Clearance details
- Applicant
- Pharmacia & Upjohn Co.
- Product code
- Code MST
- Device class
- Class 2
- Regulation
- 21 CFR 866.5750
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.