510(k) K860350

SERUM CHOLINESTERASE REAGENT SET by Sterling Diagnostics, Inc. — Product Code DLI

K860350 is an FDA 510(k) premarket notification submitted by Sterling Diagnostics, Inc. for the device "SERUM CHOLINESTERASE REAGENT SET". The FDA issued a decision of Substantially Equivalent on April 24, 1986. The device falls under product code DLI (Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase), a Class I device regulated under 21 CFR 862.3240. Sterling Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 24, 1986
Date Received: January 30, 1986
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Device Class: Class I
Regulation Number: 862.3240
Review Panel: TX
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)

510(k) K860350

Clearance Details

Device Classification

Other clearances by Sterling Diagnostics, Inc.

Other clearances for product code DLI

FDA data resources