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FDA 510(k)

IRON SET, ITEM NO. 65008

K-Number: K771927 · 1977-11-14

ApplicantHarleco
Decision Date1977-11-14
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IRON SET, ITEM NO. 65008 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-11-14 under 510(k) number K771927. The device is classified under product code JMO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRON SET, ITEM NO. 65008?

IRON SET, ITEM NO. 65008 is a medical device that received FDA 510(k) clearance on 1977-11-14. The listed applicant is Harleco. The 510(k) number is K771927.

When did IRON SET, ITEM NO. 65008 receive FDA 510(k) clearance?

IRON SET, ITEM NO. 65008 received FDA 510(k) clearance on 1977-11-14, under 510(k) number K771927.

Who is the listed applicant for IRON SET, ITEM NO. 65008?

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

What is the FDA product code for IRON SET, ITEM NO. 65008?

The FDA product code for IRON SET, ITEM NO. 65008 is JMO.

Other records listing Harleco 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.

K820233ULTRAZYME PLUS GAMMA GT(65055-65056)K813427ULTRACHEM GLUC-DHK813038ULTRACHEM TP, ITEM #64974K813041ULTRAZYME-GT, ITEM #64959 & 65032K813042ULTRACHEM GLUC-DH SET, ITEM #65048K813044ULTRACHEM ALB, ITEM #64970

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Related Devices (Code: JMO)

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.

K113438ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K061464VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668Ortho-Clinical Diagnostics, Inc.K052867VITROS CHEMISTRY PRODUCTS DTIBC REAGENTOrtho-Clinical Diagnostics, Inc.K041793OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524Olympus America, Inc.K013102WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002Wiener Laboratories SaicK012340BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)Bayer Corp.

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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