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510(k) K932713

TRACE TRANSFERRIN REAGENT by Trace Scientific , Ltd. — Product Code DDQ

K932713 is an FDA 510(k) premarket notification submitted by Trace Scientific , Ltd. for the device "TRACE TRANSFERRIN REAGENT". The FDA issued a decision of Substantially Equivalent on September 30, 1993. The device falls under product code DDQ (Antigen, Antiserum, Control, Antithrombin Iii), a Class II device regulated under 21 CFR 864.7060. Trace Scientific , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1993
Date Received
June 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Antiserum, Control, Antithrombin Iii
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

Other clearances by Trace Scientific , Ltd.

  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K981123 — UREA (April 24, 1998)
  • K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST) (September 27, 1996)
  • K961114 — AST INCORPORATING DST (May 23, 1996)
  • K961123 — ALT INCORPORATING DST (April 25, 1996)
  • K952488 — TRACE COBAS MIRA RANGE (October 13, 1995)
  • K923322 — TRACE ALBUMIN-MR REAGENT (September 11, 1992)
  • K914731 — TRACE GAMMA GT-SS REAGENT (November 19, 1991)
  • K911866 — TRACE TOTAL/DIRECT BILIRUBIN REAGENT (July 17, 1991)
  • K903897 — TRIGLYCERIDES REAGENT GPO 5 X CONC. (October 1, 1990)

Other clearances for product code DDQ

  • K972257 — N-ASSAY TIA ANTITHROMBIN III TEST KIT (October 20, 1997)
  • K935307 — DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA (November 22, 1994)
  • K780012 — ANTITHROMBIN III RIA (January 20, 1978)

FDA data resources