CDL — Berthelot Indophenol, Urea Nitrogen Class II
FDA product code CDL covers "Berthelot Indophenol, Urea Nitrogen", a Class II medical device regulated under 21 CFR 862.1770. Submissions are reviewed by the Clinical Chemistry panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CDL
- Device Class
- Class II
- Regulation Number
- 862.1770
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K896845 | reagents applications | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT | February 16, 1990 |
| K893128 | stanbio laboratory | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | July 25, 1989 |
| K871651 | biochemical trade | COLORIMETRIC BUN REAGENT KIT | May 12, 1987 |
| K864742 | tech-co | UREA NITROGEN(BUN), COLORIMETRIC METHOD | January 13, 1987 |
| K863889 | u. s. diagnostics | UREA NITROGEN TEST | November 24, 1986 |
| K863076 | j. d. assoc | UREAFAST | September 9, 1986 |
| K860154 | sterling diagnostics | BUN (ENZYMATIC BERTHELOT) REAGENT SET | February 6, 1986 |
| K831414 | bio-analytics laboratories | COLORIMETRIC BUN | June 16, 1983 |
| K822237 | sterling biochemical | UREA NITROGEN REAGENT SET (MOD. BERTHEL | August 16, 1982 |
| K810261 | volu sol medical industries | EUROCHIMA UREA NITROGEN | February 10, 1981 |
| K801727 | data medical associates | DATA-ZYME UREA NITROGEN, COLORIMETRIC | September 9, 1980 |
| K800902 | sclavo | BUN-COLOR 2, BLOOD UREA NITROGEN TEST | June 9, 1980 |
| K792417 | volu sol medical industries | ELVI BLOOD UREA NITROGEN | December 7, 1979 |
| K781899 | wako intl | UREA NITROGEN TEST | December 20, 1978 |
| K781306 | analytical and research chemicals | UREA NITROGEN TEST KIT | August 31, 1978 |
| K761152 | advanced biomedical methods | S-UREA-N, IN VITRO DIAG FOR BUN | December 9, 1976 |