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510(k) K973054

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS by Emd Chemicals, Inc. — Product Code DNN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1997
Date Received
August 15, 1997
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 Emd Chemicals, Inc.

  • K031367 — DUOPATH VEROTOXINS GLISA TEST (January 23, 2004)
  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (March 31, 1999)
  • K981926 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (July 22, 1998)
  • K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR) (December 11, 1995)
  • K951750 — GLUCOSE TEST ITEM NUMBER 97375/94 (September 6, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K945322 — PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416 (December 7, 1994)
  • K945368 — PHOSPHORUS TEST (PHOS) (December 2, 1994)
  • K840883 — UNIPAK 100 ANALYZER, 65156 & CHEMISTR (May 16, 1984)

Other clearances for product code DNN

  • K990516 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (March 31, 1999)
  • K924733 — ETHYL ALCOHOL CALIBRATORS & CONTROL (December 9, 1992)
  • K882117 — ETHYL ALCOHOL STANDARD (August 4, 1988)
  • K853532 — ALCOHOL CALIBRATORS (September 16, 1985)
  • K810466 — ETHYL ALCOHOL SERUM CALIBRATOR (March 6, 1981)
  • K802620 — EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR (October 31, 1980)