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FDA 510(k)

EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95

K-Number: K871330 · 1987-04-22

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-04-22
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 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 1987-04-22 under 510(k) number K871330. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95?

EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K871330.

When did EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 receive FDA 510(k) clearance?

EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 received FDA 510(k) clearance on 1987-04-22, under 510(k) number K871330.

Who is the listed applicant for EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95?

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 GENTAMICIN CALIBRATOR ITEM NO. 67628/95?

The FDA product code for EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 is DLJ.

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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: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)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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