Dryspot E.Coli 0157 Kit
FDA 510(k) K993401 · Oxoid , Ltd.
510(k) numberK993401
Submission
- Device name
- Dryspot E.Coli 0157 Kit
- Applicant
- Oxoid , Ltd.
Basingstoke, GB - Received
- October 8, 1999
- Decision date
- February 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GNA – Antisera, All Types, Escherichia Coli
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3255
- Specialty
- Microbiology
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Questions and answers
When was Dryspot E.Coli 0157 Kit cleared by the FDA?
Dryspot E.Coli 0157 Kit (K993401) received a 510(k) decision of Substantially Equivalent on February 28, 2000, 143 days after the submission was received.
What is the product code of K993401?
The FDA product code is GNA – Antisera, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.