Home / 510(k) Clearances / K861010

510(k) K861010

VMA BY HPLC TEST (VANILMANDELIC ACID) by Bio-Rad — Product Code CDF

K861010 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "VMA BY HPLC TEST (VANILMANDELIC ACID)". The FDA issued a decision of Substantially Equivalent on May 1, 1986. The device falls under product code CDF (Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin), a Class I device regulated under 21 CFR 862.1795. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1986
Date Received
March 18, 1986
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 Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

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)
  • 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