Product code KTQ
- Device name
- Reagent, Complement
- Medical specialty
- Immunology
- Device class
- 1
- Regulation number
- 866.4100
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890417 | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | Atlantic Antibodies | 1989-02-17 |
| K812522 | RABBIT COMPLEMENT | Dutchland Laboratories, Inc. | 1981-09-23 |
| K812369 | GUINEA PIG COMPLEMENT VIRUS ANTIBODY | Dutchland Laboratories, Inc. | 1981-09-08 |
| K812370 | GUINEA PIG COMPLEMENT REGULAR | Dutchland Laboratories, Inc. | 1981-09-08 |
| K791117 | RABBIT COMPLEMENT | Calbiochem-Behring Corp. | 1979-08-03 |
| K790380 | LOW-TOX-H RABBIT COMPLEMENT | Cederlane Labs , Ltd. | 1979-03-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00628451099291 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099284 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099161 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099154 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099062 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099079 | Standard Rabbit Complement, Frozen | Cedarlane Corporation | 2024-12-11 |
| 00628451099086 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099093 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099109 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099116 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099123 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099130 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099147 | Standard Rabbit Complement | Cedarlane Corporation | 2024-12-11 |
| 00628451099185 | Low-Tox-H Rabbit Complement | Cedarlane Corporation | 2024-12-10 |
| 00628451099215 | Low-Tox-H Rabbit Complement | Cedarlane Corporation | 2024-12-10 |
| 00628451099208 | Low-Tox-H Rabbit Complement | Cedarlane Corporation | 2024-12-10 |
| 00628451099192 | Low-Tox-H Rabbit Complement | Cedarlane Corporation | 2024-12-10 |
| 00628451099178 | Low-Tox-H Rabbit Complement | Cedarlane Corporation | 2024-12-10 |
| 06284510990066 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990073 | Standard Rabbit Complement, Frozen | Cedarlane Corporation | 2022-12-08 |
| 06284510990080 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990097 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990103 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990110 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990127 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990134 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990141 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990158 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990165 | Standard Rabbit Complement | Cedarlane Corporation | 2022-12-08 |
| 06284510990172 | Low-Tox-H Rabbit Complement | Cedarlane Corporation | 2022-12-08 |