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FDA 510(k)

AMYLASE TEST (AML) ITEM NUMBER: 65404

K-Number: K893751 · 1989-08-17

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-08-17
Product CodeJFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMYLASE TEST (AML) ITEM NUMBER: 65404 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1989-08-17 under 510(k) number K893751. 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 TEST (AML) ITEM NUMBER: 65404?

AMYLASE TEST (AML) ITEM NUMBER: 65404 is a medical device that received FDA 510(k) clearance on 1989-08-17. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K893751.

When did AMYLASE TEST (AML) ITEM NUMBER: 65404 receive FDA 510(k) clearance?

AMYLASE TEST (AML) ITEM NUMBER: 65404 received FDA 510(k) clearance on 1989-08-17, under 510(k) number K893751.

Who is the listed applicant for AMYLASE TEST (AML) ITEM NUMBER: 65404?

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

What is the FDA product code for AMYLASE TEST (AML) ITEM NUMBER: 65404?

The FDA product code for AMYLASE TEST (AML) ITEM NUMBER: 65404 is JFJ.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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