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FDA 510(k)

AMYLASE (COLORIMETRIC) REAGENT SET

K-Number: K915710 · 1992-01-30

ApplicantTech Intl. Co.
Decision Date1992-01-30
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE (COLORIMETRIC) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Tech Intl. Co.. It received FDA 510(k) clearance on 1992-01-30 under 510(k) number K915710. 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 AMYLASE (COLORIMETRIC) REAGENT SET?

AMYLASE (COLORIMETRIC) REAGENT SET is a medical device that received FDA 510(k) clearance on 1992-01-30. The listed applicant is Tech Intl. Co.. The 510(k) number is K915710.

When did AMYLASE (COLORIMETRIC) REAGENT SET receive FDA 510(k) clearance?

AMYLASE (COLORIMETRIC) REAGENT SET received FDA 510(k) clearance on 1992-01-30, under 510(k) number K915710.

Who is the listed applicant for AMYLASE (COLORIMETRIC) REAGENT SET?

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

What is the FDA product code for AMYLASE (COLORIMETRIC) REAGENT SET?

The FDA product code for AMYLASE (COLORIMETRIC) REAGENT SET is JFJ.

Related Clinical Trials

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.

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Other records listing Tech Intl. Co. 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.

K915704AMYLASE (KINETIC) REAGENT SETK915705ACID PHOSPHATASE REAGENT SETK915707AMMONIA REAGENT SETK914158URIC ACID REAGENT SETK915706LIPASE REAGENT SETK914160CHOLESTEROL REGEANT SET

View all 13 devices →

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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