DHL — Protein, Complement, Antigen, Antiserum, Control Class I
FDA product code DHL covers "Protein, Complement, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.4100. Submissions are reviewed by the Immunology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DHL
- Device Class
- Class I
- Regulation Number
- 866.4100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K870351 | diamedix | EZ COMPLEMENT REAGENTS, 78N2212 | March 13, 1987 |
| K811445 | kallestad laboratories | KALLESTAD R QUANTIPLATE ALT. PATHWAY T. | June 24, 1981 |
| K811433 | scripps-miles | SCRIPPSERA COMPLEMENT CONTROL SERA | June 16, 1981 |
| K770866 | cedarlake labs | RABBIT COMPLEMENT | June 3, 1977 |