SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
FDA 510(k) clearance K023316 · decided 2002-12-16
Clearance details
- K-number
- K023316
- Device name
- SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
- Applicant
- Lin-Zhi International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-03
- Decision date
- 2002-12-16
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- DLJ
- Device class
- 2
- Regulation number
- 862.3200
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Synnyvale, CA, 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 |
|---|
| BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2 (K132090) | Randox Laboratories, Ltd. | 2013-08-08 |
| QMS LIDOCAINE CALIBRATORS, MODEL 0374678 (K091617) | Thermo Fisher Scientific | 2009-07-17 |
| DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 (K082030) | Siemens Healthcare Diagnostics, Inc. | 2008-08-22 |
| DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (K062182) | Dade Behring, Inc. | 2006-09-14 |
| DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) (K062199) | Dade Behring, Inc. | 2006-09-06 |
| DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) (K061503) | Dade Behring, Inc. | 2006-06-22 |
| DIMENSION TACR CALIBRATOR, MODEL DC107 (K060503) | Dade Behring, Inc. | 2006-05-18 |
| DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 (K053108) | Dade Behring, Inc. | 2006-02-16 |
| DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 (K052015) | Dade Behring, Inc. | 2005-09-12 |
| LABONE MICRO-PLATE COTININE EIA (K033601) | Labone, Inc. | 2004-02-10 |
| PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS (K033246) | Roche Diagnostics Corp. | 2003-12-02 |
| PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS (K033165) | Roche Diagnostics Corp. | 2003-10-14 |
Recalls involving this device
No recalls on record reference this clearance.