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FDA 510(k)

REAGENTS FOR DETERM. SERUM IRON IN HUMAN

K-Number: K800677 · 1980-05-28

ApplicantDiagnostic Solutions, Inc.
Decision Date1980-05-28
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENTS FOR DETERM. SERUM IRON IN HUMAN is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Solutions, Inc.. It received FDA 510(k) clearance on 1980-05-28 under 510(k) number K800677. 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 REAGENTS FOR DETERM. SERUM IRON IN HUMAN?

REAGENTS FOR DETERM. SERUM IRON IN HUMAN is a medical device that received FDA 510(k) clearance on 1980-05-28. The listed applicant is Diagnostic Solutions, Inc.. The 510(k) number is K800677.

When did REAGENTS FOR DETERM. SERUM IRON IN HUMAN receive FDA 510(k) clearance?

REAGENTS FOR DETERM. SERUM IRON IN HUMAN received FDA 510(k) clearance on 1980-05-28, under 510(k) number K800677.

Who is the listed applicant for REAGENTS FOR DETERM. SERUM IRON IN HUMAN?

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

What is the FDA product code for REAGENTS FOR DETERM. SERUM IRON IN HUMAN?

The FDA product code for REAGENTS FOR DETERM. SERUM IRON IN HUMAN is JIY.

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Other records listing Diagnostic Solutions, Inc. as applicant

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.

K934892RELIEF PLUS ONE REAGENT STRIP MODIFICATIONK924398UNI-CHECK REAGENT STRIPK921825QUICK-CHECK II REAGENT STRIPK800689REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-K800681REAGENTS FOR DETERM. CO2 IN HUMAN SERUMK800691REAGENT FOR DETERM. LACTATE/DEHYDROGENAS

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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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