Diag. Conducta Rate Bun Reag. Set
FDA 510(k) K771060 · J.T. Baker Chemical Co.
510(k) numberK771060
Submission
- Device name
- Diag. Conducta Rate Bun Reag. Set
- Applicant
- J.T. Baker Chemical Co.
Mchenry, IL, US - Received
- June 13, 1977
- Decision date
- July 21, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDS – Electrode, Ion Specific, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171247 | epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide TestCDS · Traditional | Epocal, Inc. | 01/17/2018SE |
| K040973 | Bun ReagentCDS · Traditional | Genchem, Inc. | 12/27/2004SE |
| K033056 | Bun Reagent for Beckman Synchron CX & CX Delta ReagentCDS · Traditional | Diamond Diagnostics, Inc. | 01/30/2004SE |
| K925550 | Hi Chem Bun Reagent Kit,Product Number 88806CDS · Traditional | Hichem Diagnostics | 04/20/1993SE |
| K860543 | Blood Urea Nitrogen (Bun) TestcardCDS · Traditional | Ilex Corp. | 04/21/1986SE |
| K855091 | Chem-Pro 1000 Clinical Chemistry-Analysis SysCDS · Traditional | Sen Tech Medical Corp. | 03/14/1986SE |
| K812308 | Lancer Bun Rate Reagent KitCDS · Traditional | Sherwood Medical Co. | 08/31/1981SE |
| K811193 | Bun Rate ReagentCDS · Traditional | Chem-Elec, Inc. | 07/10/1981SE |
| K800616 | Bun Reagent Kit #88108CDS · Traditional | Hi Chem, Inc. | 04/10/1980SE |
| K800590 | Bun KitCDS · Traditional | Nobel Scientific Industries, Inc. | 04/04/1980SE |
More from Nobel Scientific Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K803128 | Series 810 Platelet AnalyzerGKL · Traditional | 04/03/1981SE |
| K802080 | Baker Diag. Ultrarate Chloride KitJFS · Traditional | 10/10/1980SE |
| K802035 | Baker Diag. Ultrarate CO2 Reagent KitJFL · Traditional | 09/26/1980SE |
| K801909 | Lsa 290 Assay Reagents/NephelometricDEX · Traditional | 09/26/1980SE |
| K801795 | Baker Diagnostic Ultra-Rate Sodium/Pot.JGS · Traditional | 09/16/1980SE |
| K801669 | J.T. Baker ALPHA-1-ANTITRYPSIN NepheloDEM · Traditional | 09/16/1980SE |
| K801662 | J.T. Baker ALPHA-2-MACROGLOBULIN Neph.DEP · Traditional | 09/16/1980SE |
| K801661 | J.T. Baker Ceruloplasmin NephelometricDDB · Traditional | 09/16/1980SE |
| K801362 | Albumin Nephelometric AssayJQX · Traditional | 07/21/1980SE |
| K801434 | J.T. Baker Transferrin Nephelometric AssDDG · Traditional | 07/08/1980SE |
Questions and answers
When was Diag. Conducta Rate Bun Reag. Set cleared by the FDA?
Diag. Conducta Rate Bun Reag. Set (K771060) received a 510(k) decision of Substantially Equivalent on July 21, 1977, 38 days after the submission was received.
What is the product code of K771060?
The FDA product code is CDS – Electrode, Ion Specific, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.