Owren's Veronal Buffer
FDA 510(k) K883484 · Helena Laboratories
510(k) numberK883484
Submission
- Device name
- Owren's Veronal Buffer
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- August 16, 1988
- Decision date
- August 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Owren's Veronal Buffer cleared by the FDA?
Owren's Veronal Buffer (K883484) received a 510(k) decision of Substantially Equivalent on August 25, 1988, 9 days after the submission was received.
What is the product code of K883484?
The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.