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510(k) K920223

CHEM CHEX THEOPHYLLINE CONTROL by Streck Laboratories, Inc. — Product Code LAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1992
Date Received
January 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Theophylline Control Materials
Device Class
Class I
Regulation Number
862.3280
Review Panel
TX
Submission Type

Other clearances by Streck Laboratories, Inc.

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  • K040107 — CYTO-CHEX BCT (July 27, 2004)
  • K040025 — A1C-CELLULAR (March 2, 2004)
  • K023656 — SICKLE-CHEX SOLUBILITY KIT (December 30, 2002)
  • K021922 — MODIFICATION TO PARA 5X (June 25, 2002)
  • K020469 — CAL-CHEX CD PLUS (April 4, 2002)
  • K013316 — SICKLE-CHEX (November 6, 2001)
  • K011410 — PARA 5X (June 26, 2001)
  • K001443 — SUGAR CHEX ONE (June 29, 2000)
  • K000945 — PARA 12 PLUS RETICS (April 18, 2000)

Other clearances for product code LAW

  • K914251 — MODEL IRC PASSPORT NEBULIZER (January 24, 1992)
  • K903924 — BIOTRACK THEOPHYLLINE QUALITY CONTROLS (September 17, 1990)
  • K871589 — THEOPHYLLINE FPIA CONTROLS (June 17, 1987)