Solana C. difficile Assay
FDA 510(k) K170491 · Quidel Corporation
510(k) numberK170491
Submission
- Device name
- Solana C. difficile Assay
- Applicant
- Quidel Corporation
Athens, OH, US - Received
- February 17, 2017
- Decision date
- May 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OZN – C. Difficile Toxin Gene Amplification Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3130
- Specialty
- Microbiology
Amplification assay for the detection of c. Difficile toxin genes from stool specimens of symptomatic patients.
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| K142422 | cobas Cdiff TestOZN · Traditional | Roche Molecular Systems, Inc. | 05/20/2015SE |
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Questions and answers
When was Solana C. difficile Assay cleared by the FDA?
Solana C. difficile Assay (K170491) received a 510(k) decision of Substantially Equivalent on May 11, 2017, 83 days after the submission was received.
What is the product code of K170491?
The FDA product code is OZN – C. Difficile Toxin Gene Amplification Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3130.