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FDA 510(k)

IL TEST IRON

K-Number: K972363 · 1997-08-15

ApplicantInstrumentation Laboratory CO
Decision Date1997-08-15
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IL TEST IRON is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K972363. 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 IL TEST IRON?

IL TEST IRON is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K972363.

When did IL TEST IRON receive FDA 510(k) clearance?

IL TEST IRON received FDA 510(k) clearance on 1997-08-15, under 510(k) number K972363.

Who is the listed applicant for IL TEST IRON?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IL TEST IRON?

The FDA product code for IL TEST IRON is JIY.

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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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