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510(k) K882117

ETHYL ALCOHOL STANDARD by Verichem Laboratories, Inc. — Product Code DNN

K882117 is an FDA 510(k) premarket notification submitted by Verichem Laboratories, Inc. for the device "ETHYL ALCOHOL STANDARD". The FDA issued a decision of Substantially Equivalent on August 4, 1988. The device falls under product code DNN (Calibrators, Ethyl Alcohol), a Class II device regulated under 21 CFR 862.3200. Verichem Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1988
Date Received
May 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Ethyl Alcohol
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Verichem Laboratories, Inc.

  • K112834 — MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND K (March 28, 2012)
  • K974290 — MICROPROTEIN STANDARD KIT (December 19, 1997)
  • K973345 — MATRIX PLUS MULTI-CALIBRATOR KIT (October 29, 1997)
  • K972333 — AMMONIA/IRON STANDARD KIT (July 23, 1997)
  • K924904 — HDL-CHOLESTEROL STANDARD, MODIFICATION (January 13, 1993)
  • K912513 — ELECTROLYTE CONTROL (July 19, 1991)
  • K901113 — MATRIX PLUS(TM) CHEMISTRY REFERENCE STANDARD (March 29, 1990)
  • K882059 — BILIRUBIN STANDARD (October 25, 1988)
  • K881320 — URINE TOXICOLOGY STANDARD (September 9, 1988)
  • K875285 — MULTI-CHEMISTRY LINEARITY STANDARD (September 2, 1988)

Other clearances for product code DNN

  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (March 31, 1999)
  • K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (October 1, 1997)
  • K924733 — ETHYL ALCOHOL CALIBRATORS & CONTROL (December 9, 1992)
  • K853532 — ALCOHOL CALIBRATORS (September 16, 1985)
  • K810466 — ETHYL ALCOHOL SERUM CALIBRATOR (March 6, 1981)
  • K802620 — EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR (October 31, 1980)

FDA data resources