FDA Product Code
FDA Product Code CDO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1775
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033278 | RANDOX URIC ACID | Randox Laboratories, Ltd. | 2004-02-27 | Traditional | PDF ↗ |
| K992798 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P | Sigma Diagnostics, Inc. | 1999-09-28 | Traditional | PDF ↗ |
| K982251 | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT | Sigma Diagnostics, Inc. | 1998-08-18 | Traditional | PDF ↗ |
| K981766 | URIC ACID | Abbott Laboratories | 1998-06-19 | Traditional | PDF ↗ |
| K981189 | URIC ACID | Abbott Laboratories | 1998-05-07 | Traditional | PDF ↗ |
| K971485 | URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) | Trace America, Inc. | 1997-05-27 | Traditional | PDF ↗ |
| K955752 | OLYMPUS URIC ACID REAGENT | Olympus America, Inc. | 1996-01-31 | Traditional | PDF ↗ |
| K932162 | URIC ACID TEST ITEM NUMBER 65422 | Em Diagnostic Systems, Inc. | 1993-09-27 | Traditional | PDF ↗ |
| K923765 | SYSTEMATE URICACID TEST, TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K903335 | SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 | Em Diagnostic Systems, Inc. | 1990-08-17 | Traditional | PDF ↗ |
| K875320 | BIOTROL URIC ACID ENZYMATIQUE UV H.P. | Biotrol, USA, Inc. | 1988-02-01 | Traditional | PDF ↗ |
| K873358 | GEMENI URIC ACID U.V. | Electro-Nucleonics Laboratories, Inc. | 1987-09-11 | Traditional | PDF ↗ |
| K863660 | EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 | Em Diagnostic Systems, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K844986 | ROCHE REAGENTS REAGENT FOR URIC ACID | Roche Diagnostic Systems, Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K822884 | URIC ACID 75CDO | Technicon Instruments Corp. | 1982-10-27 | Traditional | PDF ↗ |
| K821872 | ULTRACHEM URIC ACID AIDH | Harleco Diagnostics | 1982-07-14 | Traditional | PDF ↗ |
| K821474 | ULTRACHEM URIC ACID AIDH #65047 | Emd Chemicals, Inc. | 1982-06-03 | Traditional | PDF ↗ |
| K821465 | ULTRACHEM URIC ACID AIDH, #65047 | Emd Chemicals, Inc. | 1982-06-02 | Traditional | PDF ↗ |
| K821167 | URICASE (U.V.) URIC ACID | Syn-Kit, Inc. | 1982-05-14 | Traditional | PDF ↗ |
| K813244 | UV URIC ACID DETERMINATION | Biorent Diagnostic, Inc. | 1981-12-08 | Traditional | PDF ↗ |
| K812500 | ULTRACHEM URIC ACID ALDH, ITEM #65047 | Harleco | 1981-09-23 | Traditional | PDF ↗ |
| K802371 | URIC ACID/ALDH | Boehringer Mannheim Corp. | 1980-10-23 | Traditional | PDF ↗ |
| K801243 | COBAS REAGENTS FOR URIC ACID | Roche Analytical Instruments, Inc. | 1980-06-26 | Traditional | PDF ↗ |
| K800130 | CENTRIFICHEM URIC ACID | Union Carbide Corp. | 1980-02-13 | Traditional | PDF ↗ |
| K790834 | UV URIC ACID DETERMINATION | The Dow Chemical Co. | 1979-06-28 | Traditional | PDF ↗ |
| K781996 | ACID REAGENT, URIC SINGLE VIAL | Calbiochem-Behring Corp. | 1979-01-03 | Traditional | PDF ↗ |
| K780859 | PRINCETON BIOMEDIX URICASE (UV) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-07-27 | Traditional | PDF ↗ |
| K771509 | MULTISTAT III URIC ACID TEST | Instrumentation Laboratory CO | 1977-09-13 | Traditional | PDF ↗ |
| K770831 | STATZYME URIC ACID REAGENT | Worthington Biochemical Corp. | 1977-07-11 | Traditional | PDF ↗ |
| K770767 | IN VITRO DIAG. FOR URIC ACID | Smithkline Diagnostics, Inc. | 1977-07-05 | Traditional | PDF ↗ |
| K760989 | URIC ACID REAGENT SET | Worthington Biochemical Corp. | 1976-12-09 | Traditional | PDF ↗ |
Product code CDO · Class I · Clinical Chemistry. Data: openFDA.