Inorganic Phosphorus Reagents
FDA 510(k) K811222 · Connecticut Diagnostics, Ltd.
510(k) numberK811222
Submission
- Device name
- Inorganic Phosphorus Reagents
- Applicant
- Connecticut Diagnostics, Ltd.
Mchenry, IL, US - Received
- May 4, 1981
- Decision date
- May 21, 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 |
| K811864 | Sigma Procedure 265-UVCED · Traditional | Sigma Chemical Co. | 07/31/1981SE |
| 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 |
|---|---|---|
| K905617 | Visi-StaphJWX · Traditional | 03/29/1991SE |
| K822504 | CDL Auto-Lysing ReagentGGK · Traditional | 09/17/1982SE |
| K822501 | CDL Isotonic DiluentGIF · Traditional | 09/17/1982SE |
| K822500 | CDL Lysing ReagentGGK · Traditional | 09/17/1982SE |
| K801898 | Uric Acid Diagnostic ReagentKNK · Traditional | 10/10/1980SE |
| K801897 | Glucose Diagnostic ReagentCGA · Traditional | 10/10/1980SE |
| K792465 | Connecticut Diagnostics, Lts. DirectCIG · Traditional | 12/18/1979SE |
| K792362 | Blood Urea Nitrogen ReagentJGZ · Traditional | 12/06/1979SE |
| K792340 | Connect. Diag. Total Protein Diag. ReageCEK · Traditional | 12/06/1979SE |
| K792339 | Connect. Diag. Albumin Diagnostic ReagenCIX · Traditional | 12/06/1979SE |
Questions and answers
When was Inorganic Phosphorus Reagents cleared by the FDA?
Inorganic Phosphorus Reagents (K811222) received a 510(k) decision of Substantially Equivalent on May 21, 1981, 17 days after the submission was received.
What is the product code of K811222?
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.