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510(k) K853532

ALCOHOL CALIBRATORS by Diagnostic Systems — Product Code DNN

K853532 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "ALCOHOL CALIBRATORS". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code DNN (Calibrators, Ethyl Alcohol), a Class II device regulated under 21 CFR 862.3200. Diagnostic Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
August 23, 1985
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 Diagnostic Systems

  • K905146 — OLYMPUS URINE PH (February 4, 1991)
  • K893691 — EMDS CREATINE KINASE ITEM NIMBER 65411 (August 31, 1989)
  • K893692 — EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 (August 21, 1989)
  • K893966 — HDL PRECIPITATING REAGENT (July 25, 1989)
  • K884993 — VISUAL BLOOD GLUCOSE TEST SYSTEM (December 29, 1988)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (June 20, 1988)
  • K880787 — EASY-TEST LACTIC ACID (LA) (March 15, 1988)
  • K862403 — EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95 (July 11, 1986)
  • K854784 — ABSORBANCE (ABS) TEST PAK (December 19, 1985)
  • K853699 — EASY ANALYZER & EASY-TEST REAGENT (September 25, 1985)

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)
  • K882117 — ETHYL ALCOHOL STANDARD (August 4, 1988)
  • K810466 — ETHYL ALCOHOL SERUM CALIBRATOR (March 6, 1981)
  • K802620 — EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR (October 31, 1980)

FDA data resources