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510(k) K883493

TECHNICON DPA-1 IMMUNOGLOBULIN M by Technicon Instruments Corp. — Product Code DFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1988
Date Received
August 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

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Other clearances for product code DFL

  • K882822 — FIAGEN FERRITIN (August 4, 1988)
  • K772079 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M (February 3, 1978)