UREA NITROGEN TEST KIT
FDA 510(k) clearance K781306 · decided 1978-08-31
Clearance details
- K-number
- K781306
- Device name
- UREA NITROGEN TEST KIT
- Applicant
- Analytical & Research Chemicals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-28
- Decision date
- 1978-08-31
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- CDL
- Device class
- 2
- Regulation number
- 862.1770
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT (K896845) | Reagents Applications, Inc. | 1990-02-16 |
| STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 (K893128) | Stanbio Laboratory | 1989-07-25 |
| COLORIMETRIC BUN REAGENT KIT (K871651) | Biochemical Trade, Inc. | 1987-05-12 |
| UREA NITROGEN(BUN), COLORIMETRIC METHOD (K864742) | Tech-Co, Inc. | 1987-01-13 |
| UREA NITROGEN TEST (K863889) | U. S. Diagnostics, Inc. | 1986-11-24 |
| UREAFAST (K863076) | J. D. Assoc. | 1986-09-09 |
| BUN (ENZYMATIC BERTHELOT) REAGENT SET (K860154) | Sterling Diagnostics, Inc. | 1986-02-06 |
| COLORIMETRIC BUN (K831414) | Bio-Analytics Laboratories, Inc. | 1983-06-16 |
| UREA NITROGEN REAGENT SET (MOD. BERTHEL (K822237) | Sterling Biochemical, Inc. | 1982-08-16 |
| EUROCHIMA UREA NITROGEN (K810261) | Volu Sol Medical Industries | 1981-02-10 |
| DATA-ZYME UREA NITROGEN, COLORIMETRIC (K801727) | Data Medical Associates, Inc. | 1980-09-09 |
| BUN-COLOR 2, BLOOD UREA NITROGEN TEST (K800902) | Sclavo, Inc. | 1980-06-09 |
Recalls involving this device
No recalls on record reference this clearance.