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510(k) K945289

DOA - IMMUNOASSAY CUT-OFF CALIBRATOR by Medi-Tech, Inc. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1994
Date Received
October 31, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Medi-Tech, Inc.

  • K954457 — MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER (May 15, 1996)
  • K952345 — MEDI-TECH PLATFORM GUIDE CATHETER (August 17, 1995)
  • K952056 — IMMUNOASSAY DRUGS OF ABUSE CONTROLS (June 1, 1995)
  • K942551 — THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED (October 6, 1994)
  • K943290 — BILIRUBIN PLUS/PEDIATRIC CONTROLS (September 14, 1994)
  • K922990 — HEMODIALYSIS BATH (September 12, 1994)
  • K942552 — THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED (September 9, 1994)
  • K904073 — COAGULATION REFERENCE PLASMA, ABNORMAL (October 22, 1990)
  • K895819 — MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL (November 2, 1989)
  • K873295 — PROSTATIC URETHRO. BALLOON DILATATION CATHETER (July 31, 1989)

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