Extended Range HS CRP Kit, Cat No:9200
by Reference Diagnostics, Inc. 510(k)
Active
510(k) K030044
Overview
The Extended Range HS CRP Kit is a laboratory assay designed to detect and quantify C‑Reactive Protein antigen, antiserum, and control materials for high‑sensitivity testing. It is classified as a Class II device and is listed under the FDA 510(k) traditional clearance pathway as substantially equivalent to a predicate device. The kit is intended for use in immunology laboratories to support measurement of CRP levels across an extended analytical range.
The product is supplied as a complete kit identified by catalog number 9200 and is subject to FDA 510(k) clearance (K030044) with a decision date of 30 September 2003. It falls under product code DCK and is regulated as a medical device for immunology applications. The kit is manufactured by Reference Diagnostics, Inc. in Bedford, MA, United States.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030044 | Date30 Sep 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DCK
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5270
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Reference Diagnostics, Inc.
Questions
What is the Extended Range HS CRP Kit used for?
The Extended Range HS CRP Kit is designed to detect and quantify C-Reactive Protein antigen, antiserum, and control materials for high-sensitivity testing in immunology laboratories, supporting measurement of CRP levels across an extended analytical range.
How is the Extended Range HS CRP Kit supplied and identified?
The kit is supplied as a complete assay system identified by catalog number 9200 and manufactured by Reference Diagnostics, Inc. in Bedford, MA, United States.
Is the Extended Range HS CRP Kit sterile or single-use?
The device data does not specify sterility or single-use status; as a laboratory assay kit containing reagents and controls, it is intended for in vitro diagnostic use and not for direct patient contact, so sterility and single-use labeling do not apply in the same way as implantable or surgical devices.
What regulatory pathway was used for the Extended Range HS CRP Kit?
The kit was cleared through the FDA 510(k) traditional pathway as substantially equivalent to a predicate device, with clearance number K030044 granted on September 30, 2003, and is classified as a Class II medical device under product code DCK.