FDA 510(k)

DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE

K-Number: K946354 · 1995-05-08

Decision Date1995-05-08

Product CodeJMO

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1995-05-08 under 510(k) number K946354. 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 DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE?

DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE is a medical device that received FDA 510(k) clearance on 1995-05-08. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K946354.

When did DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE receive FDA 510(k) clearance?

DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE received FDA 510(k) clearance on 1995-05-08, under 510(k) number K946354.

Who is the listed applicant for DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE?

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

What is the FDA product code for DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE?

The FDA product code for DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE is JMO.

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Other records listing Data Medical Associates, Inc. as applicant

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 K971113DMA TRIGLYCERIDES PROCEDURES K961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE K955302SERUM BICARBONATE/CARBON DIOXIDE K955796IRON CALIBRATOR & CALIBRATION VERIFICATION SET K955300TOTAL BILIRUBIN PROCEDURE

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Related Devices (Code: JMO)

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 Saic K012340BAYER 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.