MJY — Kit, Serological, Negative Control Class I
FDA product code MJY covers "Kit, Serological, Negative Control", a Class I medical device regulated under 21 CFR 862.1660. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- MJY
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962399 | pyramid biological | HEPATITIS NEGATIVE CONTROL | August 2, 1996 |