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FDA 510(k)

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)

Número K: K250983 · 2026-01-30

RequerenteAsistan Medikal
Data da decisão2026-01-30
Código do produtoSCL
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) is the device name listed in this FDA 510(k) record. The listed applicant is Asistan Medikal. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K250983. The device is classified under product code SCL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Asistan Medikal. The 510(k) number is K250983.

When did Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) receive FDA 510(k) clearance?

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) received FDA 510(k) clearance on 2026-01-30, under 510(k) number K250983.

Who is the listed applicant for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

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

What is the FDA product code for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)?

The FDA product code for Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) is SCL.

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