Product code DCH— Immunology
N LATEX CRP MONO REAGENT
- Classification name
- System, Test, C-Reactive Protein, Rhodamine
- Device class
- Class 2
- Regulation
- 21 CFR 866.5270
- Advisory panel
- Immunology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code DCH
FDA has cleared device under product code DCH, all in 1996, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code DCH
Recent clearances under product code DCH
Data sourced from openFDA. This site is unofficial and independent of the FDA.