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510(k) K883118

ON THE SPOT CANDIDASURE by Medi-Tech, Inc. — Product Code LRF

K883118 is an FDA 510(k) premarket notification submitted by Medi-Tech, Inc. for the device "ON THE SPOT CANDIDASURE". The FDA issued a decision of Substantially Equivalent on September 30, 1988. The device falls under product code LRF (Candida Spp., Direct Antigen, Id), a Class II device regulated under 21 CFR 866.3165. Medi-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1988
Date Received
July 25, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Candida Spp., Direct Antigen, Id
Device Class
Class II
Regulation Number
866.3165
Review Panel
MI
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)
  • K945289 — DOA - IMMUNOASSAY CUT-OFF CALIBRATOR (December 13, 1994)
  • 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)

Other clearances for product code LRF

  • K863499 — CANDIDATE(R) SUPER (March 19, 1987)
  • K843286 — EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (October 1, 1984)

FDA data resources