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FDA 510(k)

TOTAL IRON BINDING CAPACITY TEST

K-Number: K884649 · 1988-12-14

ApplicantSclavo, Inc.
Decision Date1988-12-14
Product CodeJQE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL IRON BINDING CAPACITY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1988-12-14 under 510(k) number K884649. The device is classified under product code JQE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL IRON BINDING CAPACITY TEST?

TOTAL IRON BINDING CAPACITY TEST is a medical device that received FDA 510(k) clearance on 1988-12-14. The listed applicant is Sclavo, Inc.. The 510(k) number is K884649.

When did TOTAL IRON BINDING CAPACITY TEST receive FDA 510(k) clearance?

TOTAL IRON BINDING CAPACITY TEST received FDA 510(k) clearance on 1988-12-14, under 510(k) number K884649.

Who is the listed applicant for TOTAL IRON BINDING CAPACITY TEST?

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

What is the FDA product code for TOTAL IRON BINDING CAPACITY TEST?

The FDA product code for TOTAL IRON BINDING CAPACITY TEST is JQE.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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Related Devices (Code: JQE)

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.

K970248CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEMCanyon Diagnostics, Inc.K934358KODAK EKTACHEM DT SLIDES (FE)Eastman Kodak CompanyK910672J&S PEDIATRIC IRON SATURATING REAGENTJ.S. Medical Assoc.K864548ALFERR TIBC TUBEBenchmark ReagentsK842019TIBC PRETREATMENT KITE.I. Dupont DE Nemours & Co., Inc.

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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