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510(k) K832258

GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC by Gelco Diagnostics, Inc. — Product Code DEW

K832258 is an FDA 510(k) premarket notification submitted by Gelco Diagnostics, Inc. for the device "GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC". The FDA issued a decision of Substantially Equivalent on October 31, 1983. The device falls under product code DEW (Igg, 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
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Gelco Diagnostics, Inc.

  • K832266 — FITC GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832256 — GOAT ANTI-HUMAN IMMUNOGLOBULINS- (October 31, 1983)
  • K832262 — FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS (October 31, 1983)
  • K832263 — FITC GOAT ANTI-HUMAN IGA A CHAIN (October 31, 1983)
  • K832267 — FITC GOAT ANTI-HUMAN LAMBA (October 31, 1983)
  • K832270 — GOAT ANTI-HUMAN LAMBA (October 31, 1983)
  • K832260 — GOAT ANTI-HUMAN KAPPA AFFINITY (October 31, 1983)
  • K832265 — FITC GOAT ANTI-HUMAN IGM H CHAIN (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 DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K010617 — SPIFE IFE CALIBRATOR AND CONTROL KIT (March 15, 2001)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)

FDA data resources