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FDA 510(k)

EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95

K-Number: K864041 · 1986-11-25

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-11-25
Product CodeKLS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 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 1986-11-25 under 510(k) number K864041. 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 EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95?

EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 is a medical device that received FDA 510(k) clearance on 1986-11-25. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K864041.

When did EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 receive FDA 510(k) clearance?

EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 received FDA 510(k) clearance on 1986-11-25, under 510(k) number K864041.

Who is the listed applicant for EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95?

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 EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95?

The FDA product code for EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 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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