simpli-COLLECT 性传播感染检测
K号: K243410 · 2025-01-30
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决定日期2025-01-30
产品代码QYA
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器械摘要
simpli-COLLECT STI Test is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular. It received FDA 510(k) clearance on 2025-01-30 under 510(k) number K243410. The device is classified under product code QYA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the simpli-COLLECT STI Test?
simpli-COLLECT STI Test is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Abbott Molecular. The 510(k) number is K243410.
When did simpli-COLLECT STI Test receive FDA 510(k) clearance?
simpli-COLLECT STI Test received FDA 510(k) clearance on 2025-01-30, under 510(k) number K243410.
Who is the listed applicant for simpli-COLLECT STI Test?
The FDA 510(k) record lists Abbott Molecular as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for simpli-COLLECT STI Test?
The FDA product code for simpli-COLLECT STI Test is QYA.
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列明Abbott Molecular为申报人的其他记录
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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