Duopath Verotoxins Glisa Test
FDA 510(k) K031367 · Emd Chemicals, Inc.
510(k) numberK031367
Submission
- Device name
- Duopath Verotoxins Glisa Test
- Applicant
- Emd Chemicals, Inc.
Gibbstown, NJ, US - Received
- April 30, 2003
- Decision date
- January 23, 2004
- 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 Duopath Verotoxins Glisa Test cleared by the FDA?
Duopath Verotoxins Glisa Test (K031367) received a 510(k) decision of Substantially Equivalent on January 23, 2004, 268 days after the submission was received.
What is the product code of K031367?
The FDA product code is GNA – Antisera, All Types, Escherichia Coli, a Class I (low risk) device regulated under 21 CFR 866.3255.