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510(k) K831903

FLUORESCEIN CONJUGATED IMMUNOGLOBULIN by Dako Corp. — Product Code DES

K831903 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "FLUORESCEIN CONJUGATED IMMUNOGLOBULIN". The FDA issued a decision of Substantially Equivalent on Jul 19, 1983. The device falls under product code DES (Lambda, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. Dako Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 19, 1983
Date Received
Jun 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Dako Corp.

  • K041627 — CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR (Sep 3, 2004)
  • K032692 — DAKOCYTOMATION BETA-2-MICROGLOBULIN KIT, CODE NO. OA 368 (Jan 22, 2004)
  • K020023 — DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY (Feb 28, 2002)
  • K993957 — DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR (Mar 3, 2000)
  • K991454 — MOUSE IGG1 NEGATIVE CONTROLS (Jun 21, 1999)
  • K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T (Jun 21, 1999)
  • K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37 (Jul 22, 1998)
  • K971905 — DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLON (Dec 12, 1997)
  • K965022 — MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMA (Nov 6, 1997)
  • K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RP (Jun 24, 1997)

Other clearances for product code DES

  • K832267 — FITC GOAT ANTI-HUMAN LAMBA (Oct 31, 1983)

FDA data resources