URIC ACID REAGENT SET (COLORIMETRIC)
FDA 510(k) clearance K860142 · decided 1986-02-11
Clearance details
- K-number
- K860142
- Device name
- URIC ACID REAGENT SET (COLORIMETRIC)
- Applicant
- Sterling Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-14
- Decision date
- 1986-02-11
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- LFQ
- Device class
- 1
- Regulation number
- 862.1775
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sterling Heights, MI, 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 (K860111) | Technostics Intl. | 1986-02-19 |
| URIC ACID REAGENT SET (K844075) | Livonia Diagnostics, Inc. | 1984-10-30 |
| SANDARE URIC ACID PROCEDURE (K812313) | Sandare Chemical Co., Inc. | 1981-09-01 |
| URIC ACID REAGENT SET (K811764) | Anco Medical Reagents & Assoc. | 1981-08-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC recall (Z-0937-2017) | Sterling Diagnostics, Inc. | 2016-12-29 |