Flow-Pac Urea Nitrogen Reagent Set 2214, 2814
FDA 510(k) K871320 · American Research Products Co.
510(k) numberK871320
Submission
- Device name
- Flow-Pac Urea Nitrogen Reagent Set 2214, 2814
- Applicant
- American Research Products Co.
Solon, OH, US - Received
- April 3, 1987
- Decision date
- April 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDW – Diacetyl-Monoxime, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K874532 | Blood Urea NitrogenCDW · Traditional | Catachem, Inc. | 01/05/1988SE |
| K863425 | Amresco Flow Pac Urea Nitrogen Reagents #1346CDW · Traditional | American Research Products Co. | 10/01/1986SE |
| K861775 | Twin Bun/GlucoseCDW · Traditional | Boehringer Mannheim Corp. | 06/27/1986SE |
| K860419 | Urea Nitrogen Reagent SetCDW · Traditional | Sterling Diagnostics, Inc. | 02/11/1986SE |
| K850937 | UreaCDW · Traditional | Dilab, Inc. | 06/10/1985SE |
| K844156 | Urea Nitrogen Reagent SetCDW · Traditional | Livonia Diagnostics, Inc. | 11/13/1984SE |
| K841068 | Urea Nitrogen Reagent SetCDW · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K822323 | Ultrachem Bun-Uv, 65080 & 65081CDW · Traditional | Harleco Diagnostics | 09/02/1982SE |
| K821212 | Urea Nitrogen Reagent SetCDW · Traditional | Omega Medical Electronics | 07/22/1982SE |
| K813415 | Urea Nitrogen Reagent SetCDW · Traditional | Anco Medical Reagents & Assoc. | 12/31/1981SE |
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| K900667 | Amresco Ldh-L Reagents Products #7710, 7711CFJ · Traditional | 04/19/1990SE |
| K900666 | Amresco Creatinine Reagents Product #7790, 7791CGX · Traditional | 04/19/1990SE |
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Questions and answers
When was Flow-Pac Urea Nitrogen Reagent Set 2214, 2814 cleared by the FDA?
Flow-Pac Urea Nitrogen Reagent Set 2214, 2814 (K871320) received a 510(k) decision of Substantially Equivalent on April 22, 1987, 19 days after the submission was received.
What is the product code of K871320?
The FDA product code is CDW – Diacetyl-Monoxime, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.