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FDA 510(k)

SERUM CHOLINESTERASE REAGENT SET

K-Number: K860350 · 1986-04-24

ApplicantSterling Diagnostics, Inc.
Decision Date1986-04-24
Product CodeDLI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SERUM CHOLINESTERASE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-04-24 under 510(k) number K860350. The device is classified under product code DLI. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM CHOLINESTERASE REAGENT SET?

SERUM CHOLINESTERASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1986-04-24. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K860350.

When did SERUM CHOLINESTERASE REAGENT SET receive FDA 510(k) clearance?

SERUM CHOLINESTERASE REAGENT SET received FDA 510(k) clearance on 1986-04-24, under 510(k) number K860350.

Who is the listed applicant for SERUM CHOLINESTERASE REAGENT SET?

The FDA 510(k) record lists Sterling Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERUM CHOLINESTERASE REAGENT SET?

The FDA product code for SERUM CHOLINESTERASE REAGENT SET is DLI.

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Other records listing Sterling Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SET

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Related Devices (Code: DLI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950180DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHODE.I. Dupont DE Nemours & Co., Inc.K930208CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICOHeraeus Kulzer, Inc.K860641EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93Em Diagnostic Systems, Inc.K833062SERUM CHOLINESTERASE REAGENT SETSterling Biochemical, Inc.K771024CHOLINESTERASE REAGENT SYSTEMAmerican Monitor Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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