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FDA 510(k)

PARAMAX AMALINE REAGENT

K-Number: K831536 · 1983-06-17

ApplicantAmerican Dade
Decision Date1983-06-17
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PARAMAX AMALINE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1983-06-17 under 510(k) number K831536. 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 PARAMAX AMALINE REAGENT?

PARAMAX AMALINE REAGENT is a medical device that received FDA 510(k) clearance on 1983-06-17. The listed applicant is American Dade. The 510(k) number is K831536.

When did PARAMAX AMALINE REAGENT receive FDA 510(k) clearance?

PARAMAX AMALINE REAGENT received FDA 510(k) clearance on 1983-06-17, under 510(k) number K831536.

Who is the listed applicant for PARAMAX AMALINE REAGENT?

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

What is the FDA product code for PARAMAX AMALINE REAGENT?

The FDA product code for PARAMAX AMALINE REAGENT is JFJ.

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Other records listing American Dade 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.

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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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