SERUM CHOLINESTERASE REAGENT SET— 510(k) K860350

Name: FDA 510(k) clearance K860350
Creator: U.S. Food and Drug Administration
Published: 1986-04-24

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860350 for SERUM CHOLINESTERASE REAGENT SET, Substantially Equivalent on 1986-04-24. Applicant: Sterling Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code DLI
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Date received: 1986-01-30
Decision date: 1986-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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K860641 — EASY-TEST (CHE) REAGENT, ITEM NO. 67522/931986-04-03
K833062 — SERUM CHOLINESTERASE REAGENT SET1983-11-25
K771024 — CHOLINESTERASE REAGENT SYSTEM1977-07-15

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K914039 — SODIUM REAGENT SET1991-10-31
K914040 — PHOSPHOLIPID REAGENT SET1991-10-30
K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)1986-07-29

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