LAS-R Human CRP Test K771535
by Hyland Therapeutic Div., Travenol Laboratories 510(k)
Active
510(k) K771535
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771535 | Date2 Sep 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Las-R Human Crp Test
- 510(k) Number
- FDA Product Code
- DCN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5270
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The LAS-R Human CRP Test is a system for detecting C-Reactive Protein. It is classified as a Class 2 device within immunology.
This device was authorized by the FDA through a 510(k) clearance (K771535) on September 2, 1977, after being deemed substantially equivalent. It was manufactured by Hyland Therapeutic Div., Travenol Laboratories.
Other devices from Hyland Therapeutic Div., Travenol Laboratories
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Questions
AI-generated answers, 6 Oct 2026
What is the LAS-R Human CRP Test used for?
The LAS-R Human CRP Test is designed to detect C-Reactive Protein in human samples. It is classified as a Class 2 device within the field of immunology.
Who manufactured the LAS-R Human CRP Test?
The LAS-R Human CRP Test was manufactured by Hyland Therapeutic Div., Travenol Laboratories.
What is the regulatory status of the LAS-R Human CRP Test?
The LAS-R Human CRP Test was cleared by the FDA through a 510(k) submission (K771535) on September 2, 1977, after being deemed substantially equivalent.