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510(k) K821097

SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA by Icl Scientific

K821097 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA". The FDA issued a decision of Substantially Equivalent on May 5, 1982. Icl Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1982
Date Received
April 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Icl Scientific

  • K883942 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL (November 10, 1988)
  • K843565 — KOVA TROL I,II, III HUMAN URINE-DRIED (October 5, 1984)
  • K833761 — THERAPEUTIC DRUG CONTROL (January 13, 1984)
  • K832823 — ENZYMUNE-TEST TSH (October 14, 1983)
  • K831383 — EVENT-TEST SLIDE (June 22, 1983)
  • K823199 — ENZYME-TEST DIGOXIN (November 29, 1982)
  • K822777 — THERAPEUTIC DRUG CONTROL (October 8, 1982)
  • K822346 — HISTIMUNE ENZYME-ANA TEST (October 8, 1982)
  • K822465 — ENZYMUNE SYSTEM I (September 14, 1982)
  • K821374 — ENZYMUNE-TEST INSULIN (May 28, 1982)

FDA data resources