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FDA 510(k)

J&S IRON REAGENTS

K-Number: K912716 · 1991-09-25

ApplicantJ.S. Medical Assoc.
Decision Date1991-09-25
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

J&S IRON REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is J.S. Medical Assoc.. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K912716. 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 J&S IRON REAGENTS?

J&S IRON REAGENTS is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is J.S. Medical Assoc.. The 510(k) number is K912716.

When did J&S IRON REAGENTS receive FDA 510(k) clearance?

J&S IRON REAGENTS received FDA 510(k) clearance on 1991-09-25, under 510(k) number K912716.

Who is the listed applicant for J&S IRON REAGENTS?

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

What is the FDA product code for J&S IRON REAGENTS?

The FDA product code for J&S IRON REAGENTS is JMO.

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Other records listing J.S. Medical Assoc. as applicant

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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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