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FDA 510(k)

REAGENT KIT, ENZYMATIC AMYLASE

K-Number: K770750 · 1977-07-05

ApplicantBeckman Instruments, Inc.
Decision Date1977-07-05
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT KIT, ENZYMATIC AMYLASE is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1977-07-05 under 510(k) number K770750. The device is classified under product code JFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT KIT, ENZYMATIC AMYLASE?

REAGENT KIT, ENZYMATIC AMYLASE is a medical device that received FDA 510(k) clearance on 1977-07-05. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K770750.

When did REAGENT KIT, ENZYMATIC AMYLASE receive FDA 510(k) clearance?

REAGENT KIT, ENZYMATIC AMYLASE received FDA 510(k) clearance on 1977-07-05, under 510(k) number K770750.

Who is the listed applicant for REAGENT KIT, ENZYMATIC AMYLASE?

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

What is the FDA product code for REAGENT KIT, ENZYMATIC AMYLASE?

The FDA product code for REAGENT KIT, ENZYMATIC AMYLASE is JFJ.

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Other records listing Beckman Instruments, Inc. as applicant

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Related Devices (Code: JFJ)

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.

K210633Amylase2Abbott Ireland Diagnostics DivisionK191454Atellica CH Amylase_2 (AMY_2)Siemens Healthcare Diagnostics, Inc.K182474alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTALBiosystems S.A.K130685HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMYHitachi Chemical Diagnostics, Inc.K122858ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL IIElitechgroupK091846SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607Beckman Coulter, 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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