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510(k) K895287

VMA EIA KIT YAMASA by Yamasa Shoy Co., Ltd. — Product Code CDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1989
Date Received
August 25, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
Device Class
Class I
Regulation Number
862.1795
Review Panel
CH
Submission Type

Other clearances by Yamasa Shoy Co., Ltd.

  • K895288 — HVA EIA KIT YAMASA (October 31, 1989)

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  • K873372 — HVA & HOMOVANILLIC ACID BY HPLC METHOD (December 22, 1987)
  • K861962 — VANILMANDELIC ACID (VMA) REAGENT SET (July 7, 1986)
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  • K853041 — TRIGLYCERIDES LCK 124 (August 12, 1985)
  • K843379 — VMA ASSAY KIT (September 28, 1984)
  • K810992 — HELENA VMA-SMC COLUMN METHOD (April 29, 1981)
  • K791837 — VMA BY COLUMN TEST (October 30, 1979)