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510(k) K934977

MODEL 5500 CEAS by Esa, Inc. — Product Code CDF

K934977 is an FDA 510(k) premarket notification submitted by Esa, Inc. for the device "MODEL 5500 CEAS". The FDA issued a decision of Substantially Equivalent on January 11, 1994. The device falls under product code CDF (Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin), a Class I device regulated under 21 CFR 862.1795. Esa, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1994
Date Received
October 19, 1993
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 Esa, Inc.

  • K032199 — ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (January 30, 2004)
  • K971640 — LEADCARE BLOOD LEAD TESTING SYSTEM (September 9, 1997)
  • K963938 — MODEL 5500 CEAS (December 26, 1996)
  • K931148 — MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (June 9, 1993)
  • K903231 — COULOCHEM II (September 27, 1990)
  • K864729 — NEUROCHEMICAL ANALYZER (April 13, 1987)

Other clearances for product code CDF

  • K953077 — PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM (January 5, 1996)
  • 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)
  • 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