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510(k) K843286

EI-CANDIDA ENZYME IMMUNOASSAY EI1001 by Immuno-Mycologics, Inc. — Product Code LRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1984
Date Received
August 21, 1984
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

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  • K830837 — LA-HISTO ANTIBODY SYSTEM #HL 1001 (May 5, 1983)
  • K810510 — YA-CRYPTO ANTIBODY TUBE AGGLUTINATION (March 20, 1981)
  • K802427 — LA-SPORO ANTIBODY SYSTEM (October 31, 1980)

Other clearances for product code LRF

  • K883118 — ON THE SPOT CANDIDASURE (September 30, 1988)
  • K863499 — CANDIDATE(R) SUPER (March 19, 1987)