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FDA 510(k)

CHOLINESTERASE REAGENT SYSTEM

K-Number: K771024 · 1977-07-15

ApplicantAmerican Monitor Corp.
Decision Date1977-07-15
Product CodeDLI
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHOLINESTERASE REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1977-07-15 under 510(k) number K771024. 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 CHOLINESTERASE REAGENT SYSTEM?

CHOLINESTERASE REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1977-07-15. The listed applicant is American Monitor Corp.. The 510(k) number is K771024.

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

CHOLINESTERASE REAGENT SYSTEM received FDA 510(k) clearance on 1977-07-15, under 510(k) number K771024.

Who is the listed applicant for CHOLINESTERASE REAGENT SYSTEM?

The FDA 510(k) record lists American Monitor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLINESTERASE REAGENT SYSTEM?

The FDA product code for CHOLINESTERASE REAGENT SYSTEM is DLI.

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Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN 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.K860350SERUM CHOLINESTERASE REAGENT SETSterling Diagnostics, Inc.K860641EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93Em Diagnostic Systems, Inc.K833062SERUM CHOLINESTERASE REAGENT SETSterling Biochemical, Inc.

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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