Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

simpli-COLLECT STI Test

K-Number: K243410 · 2025-01-30

ApplicantAbbott Molecular
Decision Date2025-01-30
Product CodeQYA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

simpli-COLLECT STI Test is a medical device manufactured by Abbott Molecular. It received FDA 510(k) clearance on 2025-01-30 under approval number K243410. The device is classified under product code QYA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Abbott Molecular. The 510(k) number is K243410.

When was simpli-COLLECT STI Test approved by the FDA?

simpli-COLLECT STI Test received FDA 510(k) clearance on 2025-01-30, under approval number K243410.

What company makes simpli-COLLECT STI Test?

simpli-COLLECT STI Test is manufactured by Abbott Molecular.

What is the FDA product code for simpli-COLLECT STI Test?

The FDA product code for simpli-COLLECT STI Test is QYA.

Other Devices by Abbott Molecular

K241580Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) PMA P120012Assay, genotyping, hepatitis c virus PMA P030052Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence PMA P160044Cytomegalovirus (cmv) dna quantitative assay

Related Devices (Code: QYA)

DEN200070Simple 2 TestLetsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)

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.

↑