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510(k) K202540

EliA Rib-P by Phadia AB — Product Code MQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2021
Date Received
September 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Ribosomal P Antibodies
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

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Other clearances for product code MQA

  • K024151 — EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (February 6, 2003)
  • K981237 — QUANTA LITE RIBOSOME P ELISA (June 5, 1998)
  • K950169 — RIBOSOMAL P EIA TEST SYSTEM (May 23, 1996)