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FDA 510(k)

EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93

K-Number: K862350 · 1986-07-07

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-07-07
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 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 1986-07-07 under 510(k) number K862350. The device is classified under product code KLS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93?

EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K862350.

When did EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 receive FDA 510(k) clearance?

EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 received FDA 510(k) clearance on 1986-07-07, under 510(k) number K862350.

Who is the listed applicant for EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93?

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 EMIT* THEOPHYLLINE(THEO) ITEM 67533/93?

The FDA product code for EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 is KLS.

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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: KLS)

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.

K042520VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND IIIOrtho-Clinical Diagnostics, Inc.K042407EMIT CAFFEINE ASSAYDade Behring, Inc.K020740ROCHE ONLINE THEOPHYLLINERoche Diagnostics Corp.K011771RANDOX THEOPHYLLINERandox Laboratories, Ltd.K013272ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAYBayer Corp.K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229Syva Co., Dade Behring, 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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