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510(k) K842707

ADP NDNA IFA TEST by Apple Diagnostic Products — Product Code KTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1984
Date Received
July 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Dna Indirect Immunofluorescent Solid Phase
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Apple Diagnostic Products

  • K844287 — ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII (January 7, 1985)
  • K843745 — ADP ANA APPLEZYME (October 25, 1984)
  • K843120 — APPLELISA CHLAMYDIA TRACHOMATIS ANTI (September 12, 1984)
  • K842183 — ADP ANA IFA TEST (June 22, 1984)
  • K834241 — ANA APPLELISA (April 4, 1984)
  • K834242 — ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS (March 2, 1984)

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  • K905386 — DISTAT ANTI-DSDNA KIT (December 13, 1990)