510(k) K132090
- Device
- BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2
- Applicant
- RANDOX LABORATORIES, LTD.
- 510(k) number
- K132090
- Product code
- DLJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-08-08
- Date received
- 2013-07-12
- Regulation
- 862.3200
- Classification name
- Calibrators, Drug Specific
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULINE ARMSTRONG
- Address
- 55 Diamond Rd. Crumlin GB BT29 4QY BT29 4QY
FDA Registration Numbers#
- 2020952
- 8020316
- 3006198300
- 2431530
- 2029275
- 3003795116
- 2030861
- 1181121
- 2050012
- 3005333358
- 3003951180
- 9610529
- 2432235
- 3012963943
- 2250051
- 1319808
- 3010939897
- 3002809144
- 1181055
- 2517506
- 2521625
- 1827821
- 1643621
- 3005755244
- 9610746
- 3004493545
- 1415939
- 3002642396
- 2050010
- 3037000637
- 3003871639
- 1219913
- 9610126
- 1220972
- 1319681
- 3005567065
- 9612890
- 3003610499
- 3000308930
- 3003561301
Source Documents#
Other 510(k) Records For Product Code DLJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091617 | QMS LIDOCAINE CALIBRATORS, MODEL 0374678 | Thermo Fisher Scientific | 2009-07-17 |
| K082030 | DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 | Siemens Healthcare Diagnostics, Inc. | 2008-08-22 |
| K062182 | DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 | Dade Behring, Inc. | 2006-09-14 |
| K062199 | DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) | Dade Behring, Inc. | 2006-09-06 |
| K061503 | DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) | Dade Behring, Inc. | 2006-06-22 |
| K060503 | DIMENSION TACR CALIBRATOR, MODEL DC107 | Dade Behring, Inc. | 2006-05-18 |
| K053108 | DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 | Dade Behring, Inc. | 2006-02-16 |
| K052015 | DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 | Dade Behring, Inc. | 2005-09-12 |
| K033601 | LABONE MICRO-PLATE COTININE EIA | Labone, Inc. | 2004-02-10 |
| K033246 | PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS | Roche Diagnostics Corp. | 2003-12-02 |
| K033165 | PRECISET DAT AMPHETAMINE CALIBRATORS; CFAS DAT QUALITATIVE AMPHETAMINE CALIBRATORS | Roche Diagnostics Corp. | 2003-10-14 |
| K023780 | DRI PRIMIDONE CALIBRATORS | Microgenics Corp. | 2003-02-10 |
| K023316 | SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2002-12-16 |
| K021449 | CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS | Lin-Zhi International, Inc. | 2002-06-18 |
| K020845 | EMIT 2000 VANCOMYCIN CALIBRATORS | Dade Behring, Inc. | 2002-05-08 |
Legacy Summary#
summary
FDA Review#
Decision Summary