DGJ · Colostrum, Antigen, Antiserum, Control
Immunology · 21 CFR 866.5230 · Class 1
Overview
| Product Code | DGJ |
|---|---|
| Device Name | Colostrum, Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5230 |
| Device Class | Class 1 |
| Review Panel | Immunology |
Identification
A colostrum immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific proteins in colostrum. Colostrum is a substance excreted by the mammary glands during pregnancy and until production of breast milk begins 1 to 5 days after childbirth.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890689 | ADX TM OPIATES | Abbott Laboratories | Aug 25, 1989 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
