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510(k) K914039

SODIUM REAGENT SET by Sterling Diagnostics, Inc. — Product Code CEI

K914039 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "SODIUM REAGENT SET". The FDA issued a decision of Substantially Equivalent on October 31, 1991. The device falls under product code CEI (Uranyl Acetate/Zinc Acetate, Sodium), a Class II device regulated under 21 CFR 862.1665. Sterling Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1991
Date Received
September 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uranyl Acetate/Zinc Acetate, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Sterling Diagnostics, Inc.

  • K921412 — MICROPROTEIN REAGENT SET (January 21, 1993)
  • K914609 — TRIGLYCERIDES REAGENT SET (November 7, 1991)
  • K914040 — PHOSPHOLIPID REAGENT SET (October 30, 1991)
  • K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) (July 29, 1986)
  • K861962 — VANILMANDELIC ACID (VMA) REAGENT SET (July 7, 1986)
  • K862256 — ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET (July 1, 1986)
  • K862210 — UREA NITROGEN (GLDH) REAGENT SET (UV) (July 1, 1986)
  • K862209 — ALT (SGPT) REAGENT SET (UV RATE) (June 25, 1986)
  • K861855 — HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET (June 16, 1986)
  • K861615 — SALICYLATE REAGENT SET (May 23, 1986)

Other clearances for product code CEI

  • K043268 — SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2 (February 15, 2005)
  • K902572 — SODIUM REAGENT SET (July 10, 1990)
  • K832552 — SODIUM TEST KIT (September 20, 1983)

FDA data resources