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FDA 510(k)

EASY-TEST AMMONIA (AMON) ITEM NO. 16695

K-Number: K872110 · 1987-07-01

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-07-01
Product CodeJIF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST AMMONIA (AMON) ITEM NO. 16695 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 1987-07-01 under 510(k) number K872110. The device is classified under product code JIF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-TEST AMMONIA (AMON) ITEM NO. 16695?

EASY-TEST AMMONIA (AMON) ITEM NO. 16695 is a medical device that received FDA 510(k) clearance on 1987-07-01. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K872110.

When did EASY-TEST AMMONIA (AMON) ITEM NO. 16695 receive FDA 510(k) clearance?

EASY-TEST AMMONIA (AMON) ITEM NO. 16695 received FDA 510(k) clearance on 1987-07-01, under 510(k) number K872110.

Who is the listed applicant for EASY-TEST AMMONIA (AMON) ITEM NO. 16695?

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 EASY-TEST AMMONIA (AMON) ITEM NO. 16695?

The FDA product code for EASY-TEST AMMONIA (AMON) ITEM NO. 16695 is JIF.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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: JIF)

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.

K183517Ammonia IIRoche Diagnostics Operations (Rdo)K123677DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)Siemens Healthcare DiagnosticsK123320DIMENSION AMMONIA FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK062316DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGEDade Behring, Inc.K051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. SrlK033921AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.

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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