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510(k) K790257

SYSTEMIC LUPUS by Icl Scientific — Product Code DHC

K790257 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "SYSTEMIC LUPUS". The FDA issued a decision of Substantially Equivalent on March 15, 1979. The device falls under product code DHC (System, Test, Systemic Lupus Erythematosus), a Class II device regulated under 21 CFR 866.5820. Icl Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1979
Date Received
February 6, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Systemic Lupus Erythematosus
Device Class
Class II
Regulation Number
866.5820
Review Panel
IM
Submission Type

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)
  • K822346 — HISTIMUNE ENZYME-ANA TEST (October 8, 1982)
  • K822777 — THERAPEUTIC DRUG CONTROL (October 8, 1982)
  • K822465 — ENZYMUNE SYSTEM I (September 14, 1982)
  • K821374 — ENZYMUNE-TEST INSULIN (May 28, 1982)

Other clearances for product code DHC

  • K001352 — REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (April 9, 2001)
  • K001398 — REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT (March 30, 2001)
  • K930247 — HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE (March 10, 1993)
  • K930421 — ELIAS DSDNA ABS (March 10, 1993)
  • K914801 — IMMUNOWELL DSDNA ANTIBODY TEST (December 9, 1991)
  • K885048 — ACCESS R-CLONE ANA PROFILE ASSAY (January 24, 1989)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • K821385 — SERO/TEX LE TEST (May 28, 1982)
  • K810981 — ANTI NDNA IMMUNOFLOURESCENT TEST SYS (April 29, 1981)
  • K810226 — SLE ANTI-N-DNA LATEX TEST (February 9, 1981)

FDA data resources