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FDA PRODUCT CODE · CLASS II

SDCQualitative Cleaning Process Protein Indicator

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.6930
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
ImplantLife-sustainingGMP-exemptThird-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

DEN230085Steris · 510k2024-11-12

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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