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510(k) K895288

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

K895288 is an FDA 510(k) premarket notification submitted by Yamasa Shoy Co., Ltd. for the device "HVA EIA KIT YAMASA". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code CDF (Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin), a Class I device regulated under 21 CFR 862.1795. Yamasa Shoy Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 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.

  • K895287 — VMA EIA KIT YAMASA (October 30, 1989)

Other clearances for product code CDF

  • K953077 — PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM (January 5, 1996)
  • K934977 — MODEL 5500 CEAS (January 11, 1994)
  • K895287 — VMA EIA KIT YAMASA (October 30, 1989)
  • K873372 — HVA & HOMOVANILLIC ACID BY HPLC METHOD (December 22, 1987)
  • K861962 — VANILMANDELIC ACID (VMA) REAGENT SET (July 7, 1986)
  • K861010 — VMA BY HPLC TEST (VANILMANDELIC ACID) (May 1, 1986)
  • 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)

FDA data resources