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FDA 510(k)

BECKMAN CHOLINESTERASE REAGENT KIT

K-Number: K893583 · 1989-08-15

ApplicantBeckman
Decision Date1989-08-15
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BECKMAN CHOLINESTERASE REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K893583. 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 BECKMAN CHOLINESTERASE REAGENT KIT?

BECKMAN CHOLINESTERASE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Beckman. The 510(k) number is K893583.

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

BECKMAN CHOLINESTERASE REAGENT KIT received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893583.

Who is the listed applicant for BECKMAN CHOLINESTERASE REAGENT KIT?

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

What is the FDA product code for BECKMAN CHOLINESTERASE REAGENT KIT?

The FDA product code for BECKMAN CHOLINESTERASE REAGENT KIT is DIH.

Related Clinical Trials

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Other records listing Beckman 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.

K991707MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206K971534SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROLK935362P-AMYLASE CONTROLK904219SYNCHRON CX 7 CLINICAL ANALYZERK904220SYNCHRON CX4-CE

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

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

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