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510(k) K853041

TRIGLYCERIDES LCK 124 by German American Chamber of Commerce, Inc. — Product Code CDF

K853041 is an FDA 510(k) premarket notification submitted by German American Chamber of Commerce, Inc. for the device "TRIGLYCERIDES LCK 124". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code CDF (Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin), a Class I device regulated under 21 CFR 862.1795.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1985
Date Received
July 19, 1985
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 for product code CDF

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  • K934977 — MODEL 5500 CEAS (January 11, 1994)
  • K895288 — HVA EIA KIT YAMASA (October 31, 1989)
  • 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)
  • 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