Home / 510(k) Clearances / K772151

510(k) K772151

URINARY VMA - SCREEN TEST KIT by Eppendorf-Brinkmann, Inc. — Product Code CDF

K772151 is an FDA 510(k) premarket notification submitted by Eppendorf-Brinkmann, Inc. for the device "URINARY VMA - SCREEN TEST KIT". The FDA issued a decision of Substantially Equivalent on November 30, 1977. The device falls under product code CDF (Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin), a Class I device regulated under 21 CFR 862.1795. Eppendorf-Brinkmann, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1977
Date Received
November 15, 1977
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 Eppendorf-Brinkmann, Inc.

  • K780819 — GLYCOHEMOGLOBIN-SKREEN TEST KIT (November 7, 1978)
  • K772337 — URINARY 17-KETOSTERIOD/17 (January 12, 1978)
  • K761271 — URIN. L7-OH CORTICOSTEROID T(NON HYDRO) (February 14, 1977)

Other clearances for product code CDF

  • K953077 — PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM (January 5, 1996)
  • 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)
  • K853041 — TRIGLYCERIDES LCK 124 (August 12, 1985)
  • K843379 — VMA ASSAY KIT (September 28, 1984)
  • K810992 — HELENA VMA-SMC COLUMN METHOD (April 29, 1981)

FDA data resources