SDCClass II
Qualitative Cleaning Process Protein Indicator
21 CFR 880.6930 / General Hospital
SDC is the FDA product code for Qualitative Cleaning Process Protein Indicator, a class II device type, regulated under 21 CFR 880.6930. FDA's definition for this code reads: "A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- SDC
- Device name
- Qualitative Cleaning Process Protein Indicator
- FDA definition
- A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract.
- Regulation
- 21 CFR 880.6930
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 2
Clearances, product code SDC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2024 | 1 |
Applicants with the most clearances
Product code SDC| Applicant | Clearances |
|---|---|
| STERIS Corporation | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.