URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
FDA 510(k) clearance K971485 · decided 1997-05-27
Clearance details
- K-number
- K971485
- Device name
- URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
- Applicant
- Trace America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-23
- Decision date
- 1997-05-27
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- CDO
- 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 |
|---|---|---|
| RANDOX URIC ACID (K033278) | Randox Laboratories, Ltd. | 2004-02-27 |
| SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (K992798) | Sigma Diagnostics, Inc. | 1999-09-28 |
| SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (K982251) | Sigma Diagnostics, Inc. | 1998-08-18 |
| URIC ACID (K981766) | Abbott Laboratories | 1998-06-19 |
| URIC ACID (K981189) | Abbott Laboratories | 1998-05-07 |
| OLYMPUS URIC ACID REAGENT (K955752) | Olympus America, Inc. | 1996-01-31 |
| URIC ACID TEST ITEM NUMBER 65422 (K932162) | Em Diagnostic Systems, Inc. | 1993-09-27 |
| SYSTEMATE URICACID TEST, TECHNICON RA 1000 (K923765) | Em Diagnostic Systems, Inc. | 1992-09-22 |
| SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (K903335) | Em Diagnostic Systems, Inc. | 1990-08-17 |
| BIOTROL URIC ACID ENZYMATIQUE UV H.P. (K875320) | Biotrol, USA, Inc. | 1988-02-01 |
| GEMENI URIC ACID U.V. (K873358) | Electro-Nucleonics Laboratories, Inc. | 1987-09-11 |
| EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 (K863660) | Em Diagnostic Systems, Inc. | 1986-10-29 |
Recalls involving this device
No recalls on record reference this clearance.