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510(k) K864342

MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX by Eiken Chemical Co., Inc. — Product Code CFN

K864342 is an FDA 510(k) premarket notification submitted by Eiken Chemical Co., Inc. for the device "MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX". The FDA issued a decision of Substantially Equivalent on December 1, 1986. The device falls under product code CFN (Method, Nephelometric, Immunoglobulins (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Eiken Chemical Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1986
Date Received
November 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Nephelometric, Immunoglobulins (G, A, M)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Eiken Chemical Co., Inc.

  • K191147 — OC-Auto SENSOR io iFOB Test (January 2, 2020)
  • K143325 — OC-Light S FIT (August 20, 2015)
  • K853391 — MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 (October 1, 1985)

Other clearances for product code CFN

  • K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (December 13, 2023)
  • K221114 — Immunoglobulin G (IgG) (August 2, 2023)
  • K192116 — Human IgA liquid reagent kit for Use on SPAPlus (September 4, 2019)
  • K191985 — Optilite IgA Kit (August 19, 2019)
  • K191635 — Optilite IgM Kit (July 15, 2019)
  • K191465 — Human IgM Kit for use on SPAPlus (June 27, 2019)
  • K190686 — Optilite IgM CSF Kit (May 28, 2019)
  • K183151 — Optilite IgA CSF Kit (January 23, 2019)
  • K162208 — DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (January 9, 2017)
  • K150526 — Optilite IgG4 Kit (May 30, 2015)

FDA data resources