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FDA 510(k)

EASY-TEST IRON (IRON) ITEM NO. 16686

K-Number: K892863 · 1989-06-07

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-06-07
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST IRON (IRON) ITEM NO. 16686 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 1989-06-07 under 510(k) number K892863. 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 EASY-TEST IRON (IRON) ITEM NO. 16686?

EASY-TEST IRON (IRON) ITEM NO. 16686 is a medical device that received FDA 510(k) clearance on 1989-06-07. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K892863.

When did EASY-TEST IRON (IRON) ITEM NO. 16686 receive FDA 510(k) clearance?

EASY-TEST IRON (IRON) ITEM NO. 16686 received FDA 510(k) clearance on 1989-06-07, under 510(k) number K892863.

Who is the listed applicant for EASY-TEST IRON (IRON) ITEM NO. 16686?

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 EASY-TEST IRON (IRON) ITEM NO. 16686?

The FDA product code for EASY-TEST IRON (IRON) ITEM NO. 16686 is JIY.

Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JIY)

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.

K061793DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATORDade Behring, Inc.K060264DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)Dade Behring, Inc.K051115SENTINEL IRON LIQUIDSentinel Ch. SrlK033983VITALAB IRON REAGENTClinical Data, Inc.K030528ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)Clinical DataK020816IRON-PC-SL ASSAY MODEL # 151-10, 151-26Diagnostic Chemicals , Ltd.

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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