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FDA 510(k)

EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93

K-Number: K871414 · 1987-04-23

ApplicantEm Diagnostic Systems, Inc.
Decision Date1987-04-23
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 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 1987-04-23 under 510(k) number K871414. The device is classified under product code JMO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93?

EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 is a medical device that received FDA 510(k) clearance on 1987-04-23. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K871414.

When did EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 receive FDA 510(k) clearance?

EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 received FDA 510(k) clearance on 1987-04-23, under 510(k) number K871414.

Who is the listed applicant for EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93?

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 EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93?

The FDA product code for EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 is JMO.

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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: JMO)

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.

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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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