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510(k) K895718

LITHIUM CONCENTRATE FOR A FLAME PHOTOMETER by Data Medical Associates, Inc. — Product Code JGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1989
Date Received
September 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Potassium
Device Class
Class II
Regulation Number
862.1600
Review Panel
CH
Submission Type

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  • K952437 — DMA GLUCOSE HEXOKINASE U.V. PROCEDURE (October 3, 1995)
  • K946161 — DMA TOTAL CHOLESTEROL PROCEDURE (August 23, 1995)
  • K946354 — DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE (May 8, 1995)
  • K946355 — DMA ALBUMIN PROCEDURE (March 1, 1995)

Other clearances for product code JGM

  • K862300 — AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT (July 29, 1986)
  • K831300 — MSI-NAK-50 TEST KIT (July 18, 1983)
  • K810253 — SODIUM & POTASSIUM TEST KIT (February 10, 1981)
  • K771068 — TRIGLYCERIDE KIT (July 12, 1977)