UREA NITROGEN REAGENT SET
FDA 510(k) clearance K860419 · decided 1986-02-11
Clearance details
- K-number
- K860419
- Device name
- UREA NITROGEN REAGENT SET
- Applicant
- Sterling Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-04
- Decision date
- 1986-02-11
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- CDW
- Device class
- 2
- Regulation number
- 862.1770
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sterling Heights, MI, 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 |
|---|---|---|
| BLOOD UREA NITROGEN (K874532) | Catachem, Inc. | 1988-01-05 |
| FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 (K871320) | American Research Products Co. | 1987-04-22 |
| AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 (K863425) | American Research Products Co. | 1986-10-01 |
| TWIN BUN/GLUCOSE (K861775) | Boehringer Mannheim Corp. | 1986-06-27 |
| UREA (K850937) | Dilab, Inc. | 1985-06-10 |
| UREA NITROGEN REAGENT SET (K844156) | Livonia Diagnostics, Inc. | 1984-11-13 |
| UREA NITROGEN REAGENT SET (K841068) | Medical Specialties, Inc. | 1984-05-01 |
| ULTRACHEM BUN-UV, 65080 & 65081 (K822323) | Harleco Diagnostics | 1982-09-02 |
| UREA NITROGEN REAGENT SET (K821212) | Omega Medical Electronics | 1982-07-22 |
| UREA NITROGEN REAGENT SET (K813415) | Anco Medical Reagents & Assoc. | 1981-12-31 |
| BUN COLOR REAGENT & BUN ACID USED (K802160) | Panmed, Inc. | 1980-10-10 |
| SMAC REPLACEMENT REAGENTS/OF BUN-SERUM (K800673) | Diagnostic Solutions, Inc. | 1980-05-28 |
Recalls involving this device
No recalls on record reference this clearance.