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510(k) K832265

FITC GOAT ANTI-HUMAN IGM H CHAIN by Gelco Diagnostics, Inc. — Product Code DFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1983
Date Received
June 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Gelco Diagnostics, Inc.

  • K832270 — GOAT ANTI-HUMAN LAMBA (October 31, 1983)
  • K832258 — GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC (October 31, 1983)
  • K832256 — GOAT ANTI-HUMAN IMMUNOGLOBULINS- (October 31, 1983)
  • K832267 — FITC GOAT ANTI-HUMAN LAMBA (October 31, 1983)
  • K832262 — FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (October 31, 1983)
  • K832266 — FITC GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832260 — GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832263 — FITC GOAT ANTI-HUMAN IGA A CHAIN (October 31, 1983)
  • K832261 — GOAT ANTI-HUMAN LAMBA AFFINITY (October 28, 1983)
  • K832264 — FITC GOAT ANTI-HUMAN IGG Y CHAIN (October 28, 1983)

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  • K872237 — KALLESTAD QM300 IGM ANTIBODY PACK (July 9, 1987)