Ventrezyme Vast Immuno-Peroxidase Assay
FDA 510(k) K880547 · Ventrex Laboratories, Inc.
510(k) numberK880547
Submission
- Device name
- Ventrezyme Vast Immuno-Peroxidase Assay
- Applicant
- Ventrex Laboratories, Inc.
Portland, ME, US - Received
- February 9, 1988
- Decision date
- March 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DHB – System, Test, Radioallergosorbent (Rast) Immunological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5750
- Specialty
- Immunology
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Questions and answers
When was Ventrezyme Vast Immuno-Peroxidase Assay cleared by the FDA?
Ventrezyme Vast Immuno-Peroxidase Assay (K880547) received a 510(k) decision of Substantially Equivalent on March 25, 1988, 45 days after the submission was received.
What is the product code of K880547?
The FDA product code is DHB – System, Test, Radioallergosorbent (Rast) Immunological, a Class II (moderate risk) device regulated under 21 CFR 866.5750.