KTQ · Reagent, Complement
Immunology · 21 CFR 866.4100 · Class 1
Overview
| Product Code | KTQ |
|---|---|
| Device Name | Reagent, Complement |
| 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | Atlantic Antibodies | Feb 17, 1989 | SESE |
| K812522 | RABBIT COMPLEMENT | Dutchland Laboratories, Inc. | Sep 23, 1981 | SESE |
| K812370 | GUINEA PIG COMPLEMENT REGULAR | Dutchland Laboratories, Inc. | Sep 8, 1981 | SESE |
| K812369 | GUINEA PIG COMPLEMENT VIRUS ANTIBODY | Dutchland Laboratories, Inc. | Sep 8, 1981 | SESE |
| K791117 | RABBIT COMPLEMENT | Calbiochem-Behring Corp. | Aug 3, 1979 | SESE |
| K790380 | LOW-TOX-H RABBIT COMPLEMENT | Cederlane Labs , Ltd. | Mar 21, 1979 | SESE |
Top Applicants
- Dutchland Laboratories, Inc. — 3 clearances
- Atlantic Antibodies — 1 clearance
- Calbiochem-Behring Corp. — 1 clearance
- Cederlane Labs , Ltd. — 1 clearance
