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FDA 510(k)

TOTAL IRON IN SERUM

K-Number: K782160 · 1979-01-26

ApplicantFisher Scientific Co., LLC
Decision Date1979-01-26
Product CodeJIY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL IRON IN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Scientific Co., LLC. It received FDA 510(k) clearance on 1979-01-26 under 510(k) number K782160. 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 TOTAL IRON IN SERUM?

TOTAL IRON IN SERUM is a medical device that received FDA 510(k) clearance on 1979-01-26. The listed applicant is Fisher Scientific Co., LLC. The 510(k) number is K782160.

When did TOTAL IRON IN SERUM receive FDA 510(k) clearance?

TOTAL IRON IN SERUM received FDA 510(k) clearance on 1979-01-26, under 510(k) number K782160.

Who is the listed applicant for TOTAL IRON IN SERUM?

The FDA 510(k) record lists Fisher Scientific Co., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOTAL IRON IN SERUM?

The FDA product code for TOTAL IRON IN SERUM is JIY.

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Other records listing Fisher Scientific Co., LLC 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.

K930415MICROHEMATOCRIT ROTORK915825MARATHON 6K GENERAL-PURPOSE CENTRIFUGEK915441MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGEK890534MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1K881275URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & IIK874054FISHER DIAGNOSTICS HEMATALL III LAS REAGENT

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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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