510(k) K040693
- Device
- PTS PANELS LDL CHOLESTEROL TEST STRIPS
- Applicant
- POLYMER TECHNOLOGY SYSTEMS, INC.
- 510(k) number
- K040693
- Product code
- MRR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-07-06
- Date received
- 2004-03-17
- Regulation
- 862.1475
- Classification name
- System, Test, Low Density, Lipoprotein
- 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
- MARGO ENRIGHT
- Address
- 7736 Zionsville Rd. Indianapolis IN US 46268 46268
FDA Registration Numbers#
- 8020316
- 3006716639
- 3003356736
- 2030861
- 2517506
- 3003871639
- 3003539867
- 3006198300
- 3013660430
- 3004493545
- 1319808
- 3000308930
- 2085064
- 1616487
- 3010825766
- 3002642396
- 1220972
- 3000148879
- 9610126
- 3003795116
- 3010891909
- 3003419906
- 3017379203
- 3012963943
- 1832216
- 3021841051
- 1827821
- 2250051
- 2247288
- 2050012
- 3003522182
- 9610529
- 3014325803
- 2050010
- 3007662974
- 3011080315
- 2432235
- 1319681
Source Documents#
Other 510(k) Records For Product Code MRR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | Siemens Healthcare Diagnostics, Inc. | 2024-07-26 |
| K210801 | AXINON® LDL-p Test System | Numares AG | 2023-07-19 |
| K161691 | Direct LDL Cholesterol (LDL) | Randox Laboratories Limited | 2017-03-20 |
| K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | Alfa Wassermann, Inc. | 2009-08-03 |
| K090734 | EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES | Medica Corp. | 2009-07-17 |
| K063841 | NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLS | Liposcience | 2008-07-23 |
| K051121 | DIRECT LDL CHOLESTEROL, MODEL L530-60H | Teco Diagnostics | 2005-08-08 |
| K043264 | LDL-EX SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2005-01-26 |
| K041927 | LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 | Diagnostic Chemicals , Ltd. | 2004-11-23 |
| K041720 | VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II | Ortho-Clinical Diagnostics, Inc. | 2004-08-25 |
| K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | Hemagen Diagnostics, Inc. | 2002-09-17 |
| K020724 | DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 | Dade Behring, Inc. | 2002-05-09 |
| K020575 | ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS | Elan Diagnostics | 2002-04-12 |
| K014103 | SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR | Beckman Coulter, Inc. | 2002-01-28 |
| K012287 | MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION | Roche Diagnostics Corp. | 2001-08-07 |
Legacy Summary#
summary
FDA Review#
Decision Summary