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510(k) K832262

FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS by Gelco Diagnostics, Inc. — Product Code CZN

K832262 is an FDA 510(k) premarket notification submitted by Gelco Diagnostics, Inc. for the device "FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code CZN (Iga, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Gelco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

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
Iga, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Gelco Diagnostics, Inc.

  • K832267 — FITC GOAT ANTI-HUMAN LAMBA (October 31, 1983)
  • K832266 — FITC GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832256 — GOAT ANTI-HUMAN IMMUNOGLOBULINS- (October 31, 1983)
  • K832265 — FITC GOAT ANTI-HUMAN IGM H CHAIN (October 31, 1983)
  • K832263 — FITC GOAT ANTI-HUMAN IGA A CHAIN (October 31, 1983)
  • K832258 — GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC (October 31, 1983)
  • K832270 — GOAT ANTI-HUMAN LAMBA (October 31, 1983)
  • K832260 — GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832257 — GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (October 28, 1983)
  • K832264 — FITC GOAT ANTI-HUMAN IGG Y CHAIN (October 28, 1983)

Other clearances for product code CZN

  • K891683 — TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER (April 12, 1989)
  • K855011 — QUANTIMETRIC PLUS C3 REAGENT KIT (February 26, 1986)
  • K841815 — OPTIMATE IGA TEST (June 1, 1984)
  • K832257 — GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (October 28, 1983)
  • K831909 — RABBIT ANTISERUM TO HUMAN IGA (July 18, 1983)
  • K831607 — FIAX IGA TEST KIT (June 22, 1983)

FDA data resources