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FDA 510(k)

SERUM CHOLINESTERASE REAGENT SET

K-Number: K833062 · 1983-11-25

ApplicantSterling Biochemical, Inc.
Decision Date1983-11-25
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 Biochemical, Inc.. It received FDA 510(k) clearance on 1983-11-25 under 510(k) number K833062. 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 1983-11-25. The listed applicant is Sterling Biochemical, Inc.. The 510(k) number is K833062.

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

SERUM CHOLINESTERASE REAGENT SET received FDA 510(k) clearance on 1983-11-25, under 510(k) number K833062.

Who is the listed applicant for SERUM CHOLINESTERASE REAGENT SET?

The FDA 510(k) record lists Sterling Biochemical, 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 Biochemical, 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.

K844998GLUCOSE(HEXOKINASE) REAGENT SETK844251ALT/GPT REAGENT SETK843332ALKALINE PHOSPHATASE REAGENT SETK842521AST/GOT REAGENT SET UV RATEK840064UREA NITROGEN REAGENT SETK834084HYDROXYBUTYRATE DEHYDROGENASE REAGENT

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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.K860350SERUM CHOLINESTERASE REAGENT SETSterling Diagnostics, Inc.K860641EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93Em Diagnostic Systems, 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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