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510(k) K831874

LIPASE REAGENT SET by Sterling Biochemical, Inc. — Product Code JGX

K831874 is an FDA 510(k) premarket notification submitted by Sterling Biochemical, Inc. for the device "LIPASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code JGX (Turbidimetric Method, Triglycerides), a Class I device regulated under 21 CFR 862.1705. Sterling Biochemical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1983
Date Received
June 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric Method, Triglycerides
Device Class
Class I
Regulation Number
862.1705
Review Panel
CH
Submission Type

Other clearances by Sterling Biochemical, Inc.

  • K844998 — GLUCOSE(HEXOKINASE) REAGENT SET (January 18, 1985)
  • K844251 — ALT/GPT REAGENT SET (January 8, 1985)
  • K843332 — ALKALINE PHOSPHATASE REAGENT SET (September 14, 1984)
  • K842521 — AST/GOT REAGENT SET UV RATE (August 12, 1984)
  • K840064 — UREA NITROGEN REAGENT SET (June 14, 1984)
  • K834084 — HYDROXYBUTYRATE DEHYDROGENASE REAGENT (February 4, 1984)
  • K834045 — URIC ACID REAGENT SET (January 30, 1984)
  • K833864 — AMYLASE REAGENT SET-MODIFIED CARAWAY (January 13, 1984)
  • K833062 — SERUM CHOLINESTERASE REAGENT SET (November 25, 1983)
  • K831415 — LACTIC DEHYDROGENASE REAGENT SET (June 16, 1983)

FDA data resources