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510(k) K862184

DAKO ITA, IMMUNOGLOBULIN M (IGM) by Dako Corp. — Product Code DAH

K862184 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "DAKO ITA, IMMUNOGLOBULIN M (IGM)". The FDA issued a decision of Substantially Equivalent on August 19, 1986. The device falls under product code DAH (Gamma Globulin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Dako Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
June 9, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gamma Globulin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Dako Corp.

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

Other clearances for product code DAH

  • K931247 — TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 (April 27, 1993)
  • K905149 — TITAN GEL (January 3, 1991)
  • K901805 — REP(R) IMMUNOFIX (June 6, 1990)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K883494 — TECHNICON DPA-1 IMMUNOGLOBULIN G (September 7, 1988)
  • K854944 — TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT (August 27, 1986)

FDA data resources