Phosphotungstate Reduction, Uric Acid
FDA 510(k) K813076 · American Monitor Corp.
510(k) numberK813076
Submission
- Device name
- Phosphotungstate Reduction, Uric Acid
- Applicant
- American Monitor Corp.
Mchenry, IL, US - Received
- November 2, 1981
- Decision date
- November 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDH – Acid, Uric, Phosphotungstate Reduction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1775
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K850933 | Uric AcidCDH · Traditional | Dilab, Inc. | 06/25/1985SE |
| K841067 | Uric Acid Reagent SetCDH · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K821213 | Uric Acid Reagent SetCDH · Traditional | Omega Medical Electronics | 07/13/1982SE |
| K810088 | Uric Acid (TPTZ) ColorinmetricCDH · Traditional | Bio-Analytics Laboratories, Inc. | 01/28/1981SE |
| K800672 | Smac Replacement Reagents/Determ-Uric-AcCDH · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K800190 | Stanbio Direct Uric Acid Test Set #0770CDH · Traditional | Stanbio Laboratory | 02/13/1980SE |
| K792412 | Elvi Uric AcidCDH · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K792403 | Elvi Uric Acid-Colorimetric MethodCDH · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K790019 | Serum, Uric Acid DeterminationCDH · Traditional | Fisher Scientific Co., LLC | 02/26/1979SE |
| K772082 | Enzac Uric Acid 100-TEST KitCDH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/28/1977SE |
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| 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 Phosphotungstate Reduction, Uric Acid cleared by the FDA?
Phosphotungstate Reduction, Uric Acid (K813076) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 14 days after the submission was received.
What is the product code of K813076?
The FDA product code is CDH – Acid, Uric, Phosphotungstate Reduction, a Class I (low risk) device regulated under 21 CFR 862.1775.