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FDA 510(k)

COBAS REAGENT FOR A-AMYLASE

K-Number: K801295 · 1980-07-08

ApplicantRoche Analytical Instruments, Inc.
Decision Date1980-07-08
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS REAGENT FOR A-AMYLASE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Analytical Instruments, Inc.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801295. 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 COBAS REAGENT FOR A-AMYLASE?

COBAS REAGENT FOR A-AMYLASE is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Roche Analytical Instruments, Inc.. The 510(k) number is K801295.

When did COBAS REAGENT FOR A-AMYLASE receive FDA 510(k) clearance?

COBAS REAGENT FOR A-AMYLASE received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801295.

Who is the listed applicant for COBAS REAGENT FOR A-AMYLASE?

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

What is the FDA product code for COBAS REAGENT FOR A-AMYLASE?

The FDA product code for COBAS REAGENT FOR A-AMYLASE is JFJ.

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Other records listing Roche Analytical Instruments, 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.

K801299COBAS CK-NAC REAGENTK801298COBAS REAGENT FOR TRIGLYCERIDES & COBASK801296COBAS REAGENT FOR CHOLESTEROLK801297COBAS REAGENT FOR GLUCOSE RAPIDK801243COBAS REAGENTS FOR URIC ACIDK801242COBAS REAGENT FOR ALKALINE PHOSPHATASE

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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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