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510(k) K872085

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS by Immunodiagnostics, Ltd. — Product Code LSW

K872085 is an FDA 510(k) premarket notification submitted by Immunodiagnostics, Ltd. for the device "THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS". The FDA issued a decision of Substantially Equivalent on September 1, 1987. The device falls under product code LSW (Anti-Dna Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1987
Date Received
June 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances for product code LSW

  • K172348 — AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Dem (February 16, 2018)
  • K152013 — QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Contro (April 11, 2016)
  • K081251 — MODIFICATION TO AESKULISA DS DNA G (May 13, 2008)
  • K072393 — ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (December 7, 2007)
  • K060380 — FIDIS DSDNA (May 2, 2006)
  • K041628 — AESKULISA DS DNA G (October 14, 2004)
  • K921658 — ANTI-DSDNA ANTIBODY TEST (March 22, 1993)

FDA data resources