Sigma Procedure 265-UV
FDA 510(k) K811864 · Sigma Chemical Co.
510(k) numberK811864
Submission
- Device name
- Sigma Procedure 265-UV
- Applicant
- Sigma Chemical Co.
Mchenry, IL, US - Received
- July 1, 1981
- Decision date
- July 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CED – 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1520
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CED
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894288 | Phosphorus Test Item Number 65416CED · Traditional | Em Diagnostic Systems, Inc. | 08/31/1989SE |
| K840151 | Ektachem Clinical Chem. SlidesCED · Traditional | Eastman Kodak Company | 03/22/1984SE |
| K833710 | BTC Urine LH AssayCED · Traditional | Btc Diagnostics, Inc. | 01/30/1984SE |
| K820832 | Phosphorus IlCED · Traditional | American Monitor Corp. | 04/15/1982SE |
| K812670 | Sandare Fast 340 Phosphorus ProcedureCED · Traditional | Sandare Chemical Co., Inc. | 10/02/1981SE |
| K811222 | Inorganic Phosphorus ReagentsCED · Traditional | Connecticut Diagnostics, Ltd. | 05/21/1981SE |
| K802420 | Centrifichem Inorganic PhosphorusCED · Traditional | Union Carbide Corp. | 10/31/1980SE |
| K790662 | Centrifichem Inorganic PhosphorusCED · Traditional | Union Carbide Corp. | 05/15/1979SE |
More from Union Carbide Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K933694 | Sigma Glucose ReagentCGA · Traditional | 11/04/1994SE |
| K933678 | Sigma Calcium ReagentCJY · Traditional | 03/11/1994SE |
| K933696 | Sigma Electrolyte Reference ReagentJFL · Traditional | 01/03/1994SE |
| K933691 | Sigma CO2 Alkaline Buffer ReagentJFL · Traditional | 12/17/1993SE |
| K933679 | Sigma Bun ReagentLFP · Traditional | 12/17/1993SE |
| K933703 | Sigma Wash Concentrate SolutionJJE · Traditional | 12/10/1993SE |
| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
| K933695 | Sigma Electrolyte BufferJFL · Traditional | 10/22/1993SE |
| K933697 | Sigma Cre ReagentCGX · Traditional | 10/18/1993SE |
| K933693 | Sigma CX-3 Calibration Standard Level 2JIX · Traditional | 10/13/1993SE |
Questions and answers
When was Sigma Procedure 265-UV cleared by the FDA?
Sigma Procedure 265-UV (K811864) received a 510(k) decision of Substantially Equivalent on July 31, 1981, 30 days after the submission was received.
What is the product code of K811864?
The FDA product code is CED – 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase, a Class I (low risk) device regulated under 21 CFR 862.1520.