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510(k) K871589

THEOPHYLLINE FPIA CONTROLS by Sigma Chemical Co. — Product Code LAW

K871589 is an FDA 510(k) premarket notification submitted by Sigma Chemical Co. for the device "THEOPHYLLINE FPIA CONTROLS". The FDA issued a decision of Substantially Equivalent on June 17, 1987. The device falls under product code LAW (Theophylline Control Materials), a Class I device regulated under 21 CFR 862.3280. Sigma Chemical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1987
Date Received
April 24, 1987
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 Sigma Chemical Co.

  • K933694 — SIGMA GLUCOSE REAGENT (November 4, 1994)
  • K933678 — SIGMA CALCIUM REAGENT (March 11, 1994)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933679 — SIGMA BUN REAGENT (December 17, 1993)
  • K933703 — SIGMA WASH CONCENTRATE SOLUTION (December 10, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)
  • K933695 — SIGMA ELECTROLYTE BUFFER (October 22, 1993)
  • K933697 — SIGMA CRE REAGENT (October 18, 1993)
  • K933693 — SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 (October 13, 1993)

Other clearances for product code LAW

  • K920223 — CHEM CHEX THEOPHYLLINE CONTROL (June 10, 1992)
  • K914251 — MODEL IRC PASSPORT NEBULIZER (January 24, 1992)
  • K903924 — BIOTRACK THEOPHYLLINE QUALITY CONTROLS (September 17, 1990)

FDA data resources