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510(k) K832261

GOAT ANTI-HUMAN LAMBA AFFINITY by Gelco Diagnostics, Inc. — Product Code DEH

K832261 is an FDA 510(k) premarket notification submitted by Gelco Diagnostics, Inc. for the device "GOAT ANTI-HUMAN LAMBA AFFINITY". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code DEH (Lambda, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Gelco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1983
Date Received
June 30, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Gelco Diagnostics, Inc.

  • K832256 — GOAT ANTI-HUMAN IMMUNOGLOBULINS- (October 31, 1983)
  • K832262 — FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (October 31, 1983)
  • K832267 — FITC GOAT ANTI-HUMAN LAMBA (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)
  • K832266 — FITC GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832257 — GOAT ANTI-HUMAN IGA A CHAIN SPECIFIC (October 28, 1983)

Other clearances for product code DEH

  • K172471 — VENTANA CD30 (Ber-H2) RxDx Assay (May 8, 2018)
  • K140396 — FREELITE HUMAN LAMBDA FREE KIT (April 16, 2014)
  • K083601 — LAMBDA LIGHT CHAINS (June 22, 2009)
  • K033811 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (January 30, 2004)
  • K031016 — FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETE (July 15, 2003)
  • K023131 — FREELITE HUMAN LAMBDA FREE KIT (January 21, 2003)
  • K010440 — FREELITE LAMBDA FREE KIT (April 26, 2001)
  • K010441 — FREELITE KAPPA FREE KIT (April 26, 2001)
  • K003671 — LAMBDA IMMAGE FREELITE KIT (February 1, 2001)
  • K002563 — SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (October 26, 2000)

FDA data resources