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510(k) K981926

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

K981926 is an FDA 510(k) premarket notification submitted by Emd Chemicals, Inc. for the device "ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS". The FDA issued a decision of Substantially Equivalent on July 22, 1998. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Emd Chemicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1998
Date Received
June 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
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)
  • K973054 — ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (October 1, 1997)
  • 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 DLJ

  • K132090 — BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPIN (August 8, 2013)
  • K091617 — QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (July 17, 2009)
  • K082030 — DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (August 22, 2008)
  • K062182 — DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (September 14, 2006)
  • K062199 — DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (September 6, 2006)
  • K061503 — DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (June 22, 2006)
  • K060503 — DIMENSION TACR CALIBRATOR, MODEL DC107 (May 18, 2006)
  • K053108 — DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (February 16, 2006)
  • K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (September 12, 2005)
  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)

FDA data resources