510(k) K761152
- Device
- S-UREA-N, IN VITRO DIAG FOR BUN
- Applicant
- Advanced Biomedical Methods, Inc.
- 510(k) number
- K761152
- Product code
- CDL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-09
- Date received
- 1976-11-29
- Regulation
- 862.1770
- Classification name
- Berthelot Indophenol, Urea Nitrogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1832216
- 1827821
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CDL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K896845 | RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT | Reagents Applications, Inc. | 1990-02-16 |
| K893128 | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 | Stanbio Laboratory | 1989-07-25 |
| K871651 | COLORIMETRIC BUN REAGENT KIT | Biochemical Trade, Inc. | 1987-05-12 |
| K864742 | UREA NITROGEN(BUN), COLORIMETRIC METHOD | Tech-Co, Inc. | 1987-01-13 |
| K863889 | UREA NITROGEN TEST | U. S. Diagnostics, Inc. | 1986-11-24 |
| K863076 | UREAFAST | J. D. Assoc. | 1986-09-09 |
| K860154 | BUN (ENZYMATIC BERTHELOT) REAGENT SET | Sterling Diagnostics, Inc. | 1986-02-06 |
| K831414 | COLORIMETRIC BUN | Bio-Analytics Laboratories, Inc. | 1983-06-16 |
| K822237 | UREA NITROGEN REAGENT SET (MOD. BERTHEL | Sterling Biochemical, Inc. | 1982-08-16 |
| K810261 | EUROCHIMA UREA NITROGEN | Volu Sol Medical Industries | 1981-02-10 |
| K801727 | DATA-ZYME UREA NITROGEN, COLORIMETRIC | Data Medical Associates, Inc. | 1980-09-09 |
| K800902 | BUN-COLOR 2, BLOOD UREA NITROGEN TEST | Sclavo, Inc. | 1980-06-09 |
| K792417 | ELVI BLOOD UREA NITROGEN | Volu Sol Medical Industries | 1979-12-07 |
| K781899 | UREA NITROGEN TEST | Wako Intl., Inc. | 1978-12-20 |
| K781306 | UREA NITROGEN TEST KIT | Analytical & Research Chemicals, Inc. | 1978-08-31 |