Phosphorus Il
FDA 510(k) K820832 · American Monitor Corp.
510(k) numberK820832
Submission
- Device name
- Phosphorus Il
- Applicant
- American Monitor Corp.
Walker, MI, US - Received
- March 26, 1982
- Decision date
- April 15, 1982
- 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 |
| K812670 | Sandare Fast 340 Phosphorus ProcedureCED · Traditional | Sandare Chemical Co., Inc. | 10/02/1981SE |
| K811864 | Sigma Procedure 265-UVCED · Traditional | Sigma Chemical Co. | 07/31/1981SE |
| 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 |
|---|---|---|
| K896000 | Aspartate Aminotranferase (Ast)CIT · Traditional | 01/11/1990SE |
| K895999 | PhosphorusCEO · Traditional | 01/11/1990SE |
| K896001 | Alanine Aminotransferase (Alt)CKA · Traditional | 11/13/1989SE |
| K895423 | Access Chemistry AnalyzerJJE · Traditional | 10/04/1989SE |
| K893137 | Excel (TM) Chemistry AnalyzerJJE · Traditional | 08/10/1989SE |
| K892331 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 06/20/1989SE |
| K893479 | Cholesterol Reagent SetCHH · Traditional | 06/19/1989SE |
| K892002 | Neochrome(R) III GlucoseCGA · Traditional | 06/12/1989SE |
| K890312 | Gamma-GlutamyltransferaseJQB · Traditional | 03/24/1989SE |
| K890034 | Photometric Method, Iron (Non-Heme) (75JIY)JIY · Traditional | 02/03/1989SE |
Questions and answers
When was Phosphorus Il cleared by the FDA?
Phosphorus Il (K820832) received a 510(k) decision of Substantially Equivalent on April 15, 1982, 20 days after the submission was received.
What is the product code of K820832?
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.