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510(k) K935418

SCL-70 EIA TEST KIT by David A. Fuccillo, Ph.D. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1994
Date Received
November 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by David A. Fuccillo, Ph.D.

  • K935413 — ENA EIA TEST KIT (June 2, 1994)
  • K935417 — JO-1 EIA TEST KIT (May 5, 1994)
  • K935419 — LA EIA TEST KIT (May 5, 1994)
  • K940251 — MITOCHONDRIA EIA TEST KIT (May 3, 1994)
  • K935414 — SM EIA TEST KIT (May 2, 1994)
  • K935416 — RO EIA TEST KIT (May 2, 1994)
  • K940253 — HISTONE EIA TEST KIT (May 2, 1994)
  • K935415 — RNP EIA TEST KIT (May 2, 1994)

Other clearances for product code LLL

  • K250666 — Alegria Flash CTD Screen (October 22, 2025)
  • K250408 — Alegria Flash ENA Screen (September 19, 2025)
  • K213403 — Aptiva CTD Essential Reagent (September 29, 2023)
  • K190710 — EliA SymphonyS Immunoassay (November 29, 2019)
  • K180975 — QUANTA Flash HMGCR Reagents (June 25, 2018)
  • K152635 — QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Contro (June 1, 2016)
  • K151429 — QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrol (February 12, 2016)
  • K142781 — ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody (March 31, 2015)
  • K141328 — QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS (February 12, 2015)
  • K141210 — QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS (January 29, 2015)