510(k) K122126
- Device
- DIRECT LDL/HDL CHOLESTEROL CALIBRATOR
- Applicant
- RANDOX LABORATORIES LIMITED
- 510(k) number
- K122126
- Product code
- JIS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-14
- Date received
- 2012-07-18
- Regulation
- 862.1150
- Classification name
- Calibrator, Primary
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULINE ARMSTRONG
- Address
- 34 Diamond Rd. Crumlin, County Antrim GA BT29 4QY BT29 4QY
FDA Registration Numbers#
- 2084025
- 3013660430
- 3003453957
- 3003749380
- 1825740
- 3005094123
- 3006198300
- 8020316
- 3015171822
- 2431530
- 1063851
- 2030861
- 1181121
- 9610806
- 9680746
- 2050012
- 3003539867
- 3003522182
- 2245451
- 3005333358
- 9710666
- 2432235
- 3004529019
- 1319809
- 3012963943
- 2250051
- 8023024
- 3003561301
- 1832216
- 3003419906
- 1319808
- 3008344661
- 3010939897
- 3002809144
- 9612316
- 1181055
- 1000403749
- 1318354
- 3009518015
- 2517506
- 2247288
- 2122870
- 8031673
- 1827821
- 3011989923
- 3003591759
- 3004111573
- 3010830834
- 1717966
- 9610746
- 3004493545
- 3002642396
- 2050010
- 3037000637
- 3012471076
- 2085064
- 9681753
- 3003871639
- 3002807722
- 3005529799
- 1219913
- 3007111389
- 9610126
- 1221645
- 1319681
- 3004192065
- 3005625991
- 3000308930
- 3000148879
- 2434178
- 3016698405
- 9614373
Source Documents#
Other 510(k) Records For Product Code JIS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K061251 | DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR | Dade Behring, Inc. | 2006-05-31 |
| K060266 | DIMENSION IRON CALIBRATOR | Dade Behring, Inc. | 2006-03-09 |
| K053104 | DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR | Dade Behring, Inc. | 2005-12-23 |
| K032697 | DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) | Dade Behring, Inc. | 2003-11-07 |
| K032608 | GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 2003-10-21 |
| K032296 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 2003-08-13 |
| K030964 | CALIBRATION PLASMA LMW HEPARIN | Instrumentation Laboratory CO | 2003-06-06 |
| K030546 | CRP (II) CALIBRATORS | Denka Seiken Co., Ltd. | 2003-06-02 |
| K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET | Wako Chemicals USA, Inc. | 2003-04-11 |
| K022682 | RANDOX C-REACTIVE PROTEIN CALIBRATOR | Randox Laboratories, Ltd. | 2002-11-05 |
| K022901 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS | Ortho-Clinical Diagnostics | 2002-09-27 |
| K013126 | N LP(A) STANDARD SY | Dade Behring, Inc. | 2001-11-09 |
| K012878 | THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609 | Thermo Dma, Inc. | 2001-10-16 |
| K011568 | RANDOX LIPOPROTEIN | Randox Laboratories, Ltd. | 2001-09-28 |
| K010696 | BECKMAN COULTER DNASE B CALIBRATOR | Beckman Coulter, Inc. | 2001-05-10 |
Legacy Summary#
summary
FDA Review#
Decision Summary