JQJ — Densitometeric, Protein Fractionation Class I
FDA product code JQJ covers "Densitometeric, Protein Fractionation", a Class I medical device regulated under 21 CFR 862.1630. 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
- JQJ
- Device Class
- Class I
- Regulation Number
- 862.1630
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K901463 | helena laboratories | REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) | June 12, 1990 |