REAGENTS-4 for Uric Acid Determination
FDA 510(k) K760477 · Simmler & Son, Inc.
510(k) numberK760477
Submission
- Device name
- REAGENTS-4 for Uric Acid Determination
- Applicant
- Simmler & Son, Inc.
Mchenry, IL, US - Received
- August 17, 1976
- Decision date
- October 29, 1976
- 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 |
| K813076 | Phosphotungstate Reduction, Uric AcidCDH · Traditional | American Monitor Corp. | 11/16/1981SE |
| 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 |
More from Fisher Scientific Co., LLC
| 510(k) | Device | Decision |
|---|---|---|
| K780817 | Globin-Terge · Traditional | 07/27/1978SE |
| K771906 | PhosphateCDT · Traditional | 12/06/1977SE |
| K771905 | Glycerol SubstrateCDT · Traditional | 12/06/1977SE |
| K771904 | Glycerol KinaseCDT · Traditional | 12/06/1977SE |
| K771903 | LipaseCDT · Traditional | 12/06/1977SE |
| K761086 | ReagentsJJC · Traditional | 01/12/1977SE |
| K760476 | Reagent, Lactate DehydrogenaseCFJ · Traditional | 11/01/1976SE |
| K760480 | Reagent, Total Protein DeterminationCEK · Traditional | 10/29/1976SE |
| K760479 | Reagent, Total Bilirubin DeterminationCIG · Traditional | 10/29/1976SE |
| K760478 | Reagent, Bun (Urea Nitrogen) Determ.CDW · Traditional | 10/29/1976SE |
Questions and answers
When was REAGENTS-4 for Uric Acid Determination cleared by the FDA?
REAGENTS-4 for Uric Acid Determination (K760477) received a 510(k) decision of Substantially Equivalent on October 29, 1976, 73 days after the submission was received.
What is the product code of K760477?
The FDA product code is CDH – Acid, Uric, Phosphotungstate Reduction, a Class I (low risk) device regulated under 21 CFR 862.1775.