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FDA 510(k)

ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip

K-Number: K173704 · 2018-03-02

ApplicantPhadia AB
Decision Date2018-03-02
Product CodeOYL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K173704. The device is classified under product code OYL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip?

ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Phadia AB. The 510(k) number is K173704.

When did ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip receive FDA 510(k) clearance?

ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip received FDA 510(k) clearance on 2018-03-02, under 510(k) number K173704.

Who is the listed applicant for ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip?

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

What is the FDA product code for ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip?

The FDA product code for ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip is OYL.

Other records listing Phadia AB 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.

K253367EliA CTD 13 ScreenK212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seedK210902EliA Ro52, EliA Ro60K202541EliA RNA Pol IIIK202540EliA Rib-PK202067EliA SmDP-S

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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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