Protein, Complement, Antigen, Antiserum, Control
The Complement Protein Antigen, Antiserum, and Control is an immunological reagent used in clinical laboratories to detect and measure complement proteins, which are components of the innate immune system involved in defense against pathogens and inflammatory processes. It is classified as FDA Class 1, indicating low risk, subject only to general controls without premarket notification requirements. The device is regulated under 21 CFR 866.4100 within the Immunology specialty.
Basic Information
- Product Code
- DHL
- Device Class
- FDA class 1
- Regulation Number
- 866.4100
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K870351 | EZ COMPLEMENT REAGENTS, 78N2212 | Mar 13, 1987 | Substantially Equivalent | Diamedix Corp. |
| K811445 | KALLESTAD R QUANTIPLATE ALT. PATHWAY T. | Jun 24, 1981 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K811433 | SCRIPPSERA COMPLEMENT CONTROL SERA | Jun 16, 1981 | Substantially Equivalent | Scripps-Miles, Inc. |
| K770866 | RABBIT COMPLEMENT | Jun 03, 1977 | Substantially Equivalent | Cedarlake Labs , Ltd. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.