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510(k) K883942

HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL by Icl Scientific — Product Code JJY

K883942 is an FDA 510(k) premarket notification submitted by Icl Scientific for the device "HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL". The FDA issued a decision of Substantially Equivalent on November 10, 1988. The device falls under product code JJY (Multi-Analyte Controls, All Kinds (Assayed)), a Class I device regulated under 21 CFR 862.1660. Icl Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1988
Date Received
September 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Icl Scientific

  • 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)
  • K821097 — SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA (May 5, 1982)

Other clearances for product code JJY

  • K162530 — Multichem IA Plus (March 31, 2017)
  • K163629 — Audit MicroControls Linearity FD Tumor Markers II (March 10, 2017)
  • K163015 — Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; (January 10, 2017)
  • K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Veri (January 28, 2016)
  • K150300 — Liquichek Cardiac Markers Plus Control LT (December 11, 2015)
  • K142964 — VALIDATE Anemia Calibration Verification/ Linearity Test Kit (April 30, 2015)
  • K143379 — Liquichek Maternal Serum II Control (March 13, 2015)
  • K143573 — Audit MicroControls Linearity FD Tumor Markers II (January 16, 2015)
  • K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. (December 8, 2014)
  • K142978 — Audit MicroControls Linearity LQ Special Diabetes (November 20, 2014)

FDA data resources