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FDA 510(k)

ATYPICAL CHOLINESTERASE

K-Number: K873496 · 1989-01-27

ApplicantSclavo, Inc.
Decision Date1989-01-27
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ATYPICAL CHOLINESTERASE is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1989-01-27 under 510(k) number K873496. The device is classified under product code DIH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATYPICAL CHOLINESTERASE?

ATYPICAL CHOLINESTERASE is a medical device that received FDA 510(k) clearance on 1989-01-27. The listed applicant is Sclavo, Inc.. The 510(k) number is K873496.

When did ATYPICAL CHOLINESTERASE receive FDA 510(k) clearance?

ATYPICAL CHOLINESTERASE received FDA 510(k) clearance on 1989-01-27, under 510(k) number K873496.

Who is the listed applicant for ATYPICAL CHOLINESTERASE?

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

What is the FDA product code for ATYPICAL CHOLINESTERASE?

The FDA product code for ATYPICAL CHOLINESTERASE is DIH.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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Related Devices (Code: DIH)

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.

K103373SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722Beckman Coulter, Inc.K061093CHOLINESTERASE GEN.2 TEST SYSTEMRoche Diagnostics Corp.K051444SENTINEL CHOLINESTERASE LIQUIDSentinel Ch. SrlK030045OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)Olympus America, Inc.K023992WIENER LAB COLINESTERASA AAWiener Laboratories SaicK013750ADVIA 1650 CHOLINESTERASE ASSAYBayer Diagnostics 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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