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FDA 510(k)

TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02

K-Number: K991666 · 1999-06-30

ApplicantA.P. Total Care, Inc.
Decision Date1999-06-30
Product CodeJMO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 is the device name listed in this FDA 510(k) record. The listed applicant is A.P. Total Care, Inc.. It received FDA 510(k) clearance on 1999-06-30 under 510(k) number K991666. 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 TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02?

TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 is a medical device that received FDA 510(k) clearance on 1999-06-30. The listed applicant is A.P. Total Care, Inc.. The 510(k) number is K991666.

When did TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 receive FDA 510(k) clearance?

TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 received FDA 510(k) clearance on 1999-06-30, under 510(k) number K991666.

Who is the listed applicant for TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02?

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

What is the FDA product code for TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02?

The FDA product code for TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 is JMO.

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Other records listing A.P. Total Care, Inc. as applicant

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Related Devices (Code: JMO)

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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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