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510(k) K202541

EliA RNA Pol III by Phadia AB — Product Code NYO

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
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.

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Other clearances for product code NYO

  • K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISA (March 30, 2018)
  • K070066 — QUANTA LITE RNA POL III ELISA (April 11, 2007)
  • K060431 — ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 (June 19, 2006)