CDL — Berthelot Indophenol, Urea Nitrogen Class II
FDA Device Classification
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 |