URIC ACID
FDA 510(k) clearance K850933 · decided 1985-06-25
Clearance details
- K-number
- K850933
- Device name
- URIC ACID
- Applicant
- Dilab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-07
- Decision date
- 1985-06-25
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- CDH
- Device class
- 1
- Regulation number
- 862.1775
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| URIC ACID REAGENT SET (K841067) | Medical Specialties, Inc. | 1984-05-01 |
| URIC ACID REAGENT SET (K821213) | Omega Medical Electronics | 1982-07-13 |
| PHOSPHOTUNGSTATE REDUCTION, URIC ACID (K813076) | American Monitor Corp. | 1981-11-16 |
| URIC ACID (TPTZ) COLORINMETRIC (K810088) | Bio-Analytics Laboratories, Inc. | 1981-01-28 |
| SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC (K800672) | Diagnostic Solutions, Inc. | 1980-05-28 |
| STANBIO DIRECT URIC ACID TEST SET #0770 (K800190) | Stanbio Laboratory | 1980-02-13 |
| ELVI URIC ACID (K792412) | Volu Sol Medical Industries | 1979-12-07 |
| ELVI URIC ACID-COLORIMETRIC METHOD (K792403) | Volu Sol Medical Industries | 1979-12-07 |
| SERUM, URIC ACID DETERMINATION (K790019) | Fisher Scientific Co., LLC | 1979-02-26 |
| ENZAC URIC ACID 100-TEST KIT (K772082) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-11-28 |
| URIC ACID (K771842) | Gamma Enterprises, Inc. | 1977-10-25 |
| URIC ACID TEST KIT (K770564) | Mallinckrodt Critical Care | 1977-06-03 |
Recalls involving this device
No recalls on record reference this clearance.