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FDA 510(k)

SYSTE MATE TIBC HEM NO. 67225

K-Number: K850128 · 1985-02-01

ApplicantEm Diagnostic Systems, Inc.
Decision Date1985-02-01
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTE MATE TIBC HEM NO. 67225 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 1985-02-01 under 510(k) number K850128. 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 SYSTE MATE TIBC HEM NO. 67225?

SYSTE MATE TIBC HEM NO. 67225 is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K850128.

When did SYSTE MATE TIBC HEM NO. 67225 receive FDA 510(k) clearance?

SYSTE MATE TIBC HEM NO. 67225 received FDA 510(k) clearance on 1985-02-01, under 510(k) number K850128.

Who is the listed applicant for SYSTE MATE TIBC HEM NO. 67225?

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 SYSTE MATE TIBC HEM NO. 67225?

The FDA product code for SYSTE MATE TIBC HEM NO. 67225 is JMO.

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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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