Las-R Human CRP Test
FDA 510(k) K771535 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK771535
Submission
- Device name
- Las-R Human CRP Test
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- August 10, 1977
- Decision date
- September 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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Questions and answers
When was Las-R Human CRP Test cleared by the FDA?
Las-R Human CRP Test (K771535) received a 510(k) decision of Substantially Equivalent on September 2, 1977, 23 days after the submission was received.
What is the product code of K771535?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.