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FDA 510(k)

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A

K-Number: K071255 · 2007-09-07

ApplicantHyphen Biomed
Decision Date2007-09-07
Product CodeLCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A is the device name listed in this FDA 510(k) record. The listed applicant is Hyphen Biomed. It received FDA 510(k) clearance on 2007-09-07 under 510(k) number K071255. The device is classified under product code LCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A?

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A is a medical device that received FDA 510(k) clearance on 2007-09-07. The listed applicant is Hyphen Biomed. The 510(k) number is K071255.

When did ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A receive FDA 510(k) clearance?

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A received FDA 510(k) clearance on 2007-09-07, under 510(k) number K071255.

Who is the listed applicant for ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A?

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

What is the FDA product code for ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A?

The FDA product code for ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A is LCO.

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Other records listing Hyphen Biomed as applicant

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Related Devices (Code: LCO)

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.

K243374HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.K201570PF4 Enhanced assayImmucor Gti Diagnostics, Inc.K201311PF4 IgG assayImmucor Gti Diagnostics, Inc.K170854HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory COK153137HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory COK071781PF4 IGGGenetic Testing Institute

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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