FDA 510(k)

IRON REAGENTS ITEM NUMBER: SR1017

K-Number: K890304 · 1989-02-10

Decision Date1989-02-10

Product CodeJIY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IRON REAGENTS ITEM NUMBER: SR1017 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 1989-02-10 under 510(k) number K890304. The device is classified under product code JIY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRON REAGENTS ITEM NUMBER: SR1017?

IRON REAGENTS ITEM NUMBER: SR1017 is a medical device that received FDA 510(k) clearance on 1989-02-10. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K890304.

When did IRON REAGENTS ITEM NUMBER: SR1017 receive FDA 510(k) clearance?

IRON REAGENTS ITEM NUMBER: SR1017 received FDA 510(k) clearance on 1989-02-10, under 510(k) number K890304.

Who is the listed applicant for IRON REAGENTS ITEM NUMBER: SR1017?

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 IRON REAGENTS ITEM NUMBER: SR1017?

The FDA product code for IRON REAGENTS ITEM NUMBER: SR1017 is JIY.

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Related Devices (Code: JIY)

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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.