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DIASTAT anti-Sm/RNP

Model FRNP200 · Svar Life Science AB · DI 07340058410028

LKP — Anti-Sm Antibody, Antigen And Control · Class II · 21 CFR 866.5100

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Svar Life Science AB

  • Warning Letter 2017-09-20 Svar Life Science AB
  • Warning Letter 2017-09-20 Svar Life Science AB
  • NAI 2018-04-26 Svar Life Science AB · 0 citations
  • NAI 2018-04-26 Svar Life Science AB · 0 citations
  • OAI 2017-01-19 Svar Life Science AB · 7 citations
  • OAI 2017-01-19 Svar Life Science AB · 7 citations