DHL · Protein, Complement, Antigen, Antiserum, Control
Immunology · 21 CFR 866.4100 · Class 1
Overview
| Product Code | DHL |
|---|---|
| Device Name | Protein, Complement, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.4100 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870351 | EZ COMPLEMENT REAGENTS, 78N2212 | Diamedix Corp. | Mar 13, 1987 | SESE |
| K811445 | KALLESTAD R QUANTIPLATE ALT. PATHWAY T. | Kallestad Laboratories, Inc. | Jun 24, 1981 | SESE |
| K811433 | SCRIPPSERA COMPLEMENT CONTROL SERA | Scripps-Miles, Inc. | Jun 16, 1981 | SESE |
| K770866 | RABBIT COMPLEMENT | Cedarlake Labs , Ltd. | Jun 3, 1977 | SESE |
Top Applicants
- Cedarlake Labs , Ltd. — 1 clearance
- Diamedix Corp. — 1 clearance
- Kallestad Laboratories, Inc. — 1 clearance
- Scripps-Miles, Inc. — 1 clearance
