510(k) K133519
- Device
- CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
- Applicant
- CAROLINA LIQUID CHEMISTRIES CORP.
- 510(k) number
- K133519
- Product code
- JJE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-16
- Date received
- 2013-11-15
- Regulation
- 862.2160
- Classification name
- Analyzer, Chemistry (photometric, Discrete), For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Melissa F Thompson
- Address
- 575 N. Patterson Ave., Suite 430 Winston-Salem NC US 27101 27101
FDA Registration Numbers#
- 3000148879
- 3017894300
- 3011061417
- 3009297077
- 1415939
- 8023060
- 3010825766
- 3008576040
- 3003542872
- 2915796
- 3030493719
- 3021394862
- 3007361513
- 2247288
- 8021924
- 8020316
- 2435505
- 9615837
- 3004973408
- 2030861
- 3004493545
- 3005333358
- 3017548799
- 3000308930
- 9681753
- 3002895169
- 9615037
- 1616487
- 3014325803
- 9613959
- 1319681
- 1217183
- 3008425728
- 3006716639
- 2122870
- 3005509212
- 3003402518
- 3011179004
- 2245578
- 3004529019
- 1181121
- 9614698
- 2027969
- 1643621
- 3003795116
- 3009156722
- 2016473
- 3007500635
- 3005655287
- 1220972
- 3007118747
- 9610240
- 3004438098
- 3007208259
- 3017019647
- 3005622096
- 3008244372
- 3003593973
- 1832216
- 2032839
- 3011989923
- 3012471076
- 3002806944
- 3003559191
- 9612296
- 3008517993
- 8031673
- 1317202
- 3014840402
- 3005529799
- 3012526002
- 1036362
- 9610126
- 3009984016
- 9615056
- 3008344661
- 3009518015
- 3023162659
- 9610529
Source Documents#
Other 510(k) Records For Product Code JJE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183375 | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode | Horiba, Ltd. | 2019-02-12 |
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | Jas Diagnostics, Inc. | 2014-05-15 |
| K131554 | RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT | Randox Laboratories, Ltd. | 2014-01-09 |
| K130276 | DIMENSION EXL WITH LM SYSTEM | Siemens Healthcare Diagnostics, Inc. | 2013-03-22 |
| K113253 | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT | Alfa Wassermann Diagnostic Technologies, Inc. | 2012-05-17 |
| K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM | Siemens Healthcare Diagnostics | 2011-11-22 |
| K110035 | INDIKO | Thermofisher Scientific OY | 2011-06-28 |
| K073370 | TC MATRIX CLINICAL CHEMISTRY ANALYZER | Teco Diagnostics | 2008-05-08 |
| K063144 | VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM | Ortho-Clinical Diagnostics, Inc. | 2006-11-13 |
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM | Dade Behring, Inc. | 2005-07-11 |
| K042169 | STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER | Stanbio Laboratory | 2005-03-14 |
| K040958 | PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240 | Tokyo Boeki Medical System , Ltd. | 2005-02-15 |
| K023764 | UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 | Beckman Coulter, Inc. | 2003-01-28 |
| K010500 | AUTOMATED WORKCELL CONTROL SOFTWARE | Lab-Interlink, Inc. | 2001-08-01 |
| K003721 | MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 2000-12-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary