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FDA 510(k)

IRON-PC-SL ASSAY MODEL # 151-10, 151-26

K-Number: K020816 · 2002-05-14

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2002-05-14
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON-PC-SL ASSAY MODEL # 151-10, 151-26 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2002-05-14 under 510(k) number K020816. 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-PC-SL ASSAY MODEL # 151-10, 151-26?

IRON-PC-SL ASSAY MODEL # 151-10, 151-26 is a medical device that received FDA 510(k) clearance on 2002-05-14. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K020816.

When did IRON-PC-SL ASSAY MODEL # 151-10, 151-26 receive FDA 510(k) clearance?

IRON-PC-SL ASSAY MODEL # 151-10, 151-26 received FDA 510(k) clearance on 2002-05-14, under 510(k) number K020816.

Who is the listed applicant for IRON-PC-SL ASSAY MODEL # 151-10, 151-26?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRON-PC-SL ASSAY MODEL # 151-10, 151-26?

The FDA product code for IRON-PC-SL ASSAY MODEL # 151-10, 151-26 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 DataK013097WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003Wiener Laboratories Saic

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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