Centrifichem Inorganic Phosphorus
FDA 510(k) K802420 · Union Carbide Corp.
510(k) numberK802420
Submission
- Device name
- Centrifichem Inorganic Phosphorus
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- October 6, 1980
- Decision date
- October 31, 1980
- 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 |
| K811864 | Sigma Procedure 265-UVCED · Traditional | Sigma Chemical Co. | 07/31/1981SE |
| K811222 | Inorganic Phosphorus ReagentsCED · Traditional | Connecticut Diagnostics, Ltd. | 05/21/1981SE |
| K790662 | Centrifichem Inorganic PhosphorusCED · Traditional | Union Carbide Corp. | 05/15/1979SE |
More from Union Carbide Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K830337 | Mark III Oxygen Walker Sys-Low PressBYJ · Traditional | 03/17/1983SE |
| K820836 | Mark III Oxygen Walker SystemBYJ · Traditional | 04/15/1982SE |
| K820535 | Laser Gas MixturesEWG · Traditional | 03/31/1982SE |
| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | 03/27/1981SE |
| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
Questions and answers
When was Centrifichem Inorganic Phosphorus cleared by the FDA?
Centrifichem Inorganic Phosphorus (K802420) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 25 days after the submission was received.
What is the product code of K802420?
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.