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510(k) K860554

SERUM LIPASE REAGENT SET (TURBIDIMETRIC) by Sterling Diagnostics, Inc. — Product Code CFG

K860554 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "SERUM LIPASE REAGENT SET (TURBIDIMETRIC)". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code CFG (Oil Emulsion/Thymolphthalein (Titrimetric), Lipase), a Class I device regulated under 21 CFR 862.1465. Sterling Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1986
Date Received
February 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oil Emulsion/Thymolphthalein (Titrimetric), Lipase
Device Class
Class I
Regulation Number
862.1465
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)
  • K914039 — SODIUM REAGENT SET (October 31, 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)

Other clearances for product code CFG

  • K800550 — LIPASE DETERMINATION (April 2, 1980)

FDA data resources