EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
FDA 510(k) clearance K862845 · decided 1986-08-29
Clearance details
- K-number
- K862845
- Device name
- EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
- Applicant
- Em Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-29
- Decision date
- 1986-08-29
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- LBS
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gibbstown, NJ, 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 |
|---|
| HDL-Cholesterol Gen.4 (K162593) | Roche Diagnostics Operations (Rdo) | 2016-10-19 |
| Direct HDL Cholesterol (HDL) (K153435) | Randox Laboratories, Ltd. | 2016-01-08 |
| CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT (K132711) | Carolina Liquid Chemistries Corp. | 2014-05-08 |
| VITROS CHEMISTRY PRODUCTS DHDL SLIDES (K120609) | Ortho-Clinical Diagnostics, Inc. | 2012-09-07 |
| NMR LIPOPROFILE (R) TEST AND NMR PROFILER (K111516) | Liposcience, Inc. | 2011-09-27 |
| ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS (K103747) | Elitechgroup Seppim S.A.S. | 2011-08-31 |
| EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENT (K111036) | Medica Corporation | 2011-07-12 |
| POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC (K100550) | Polymedco, Inc. | 2010-09-28 |
| HDL CHOLESTEROL (HDLX) ASSAY (K100010) | Beckman Coulter, Inc. | 2010-05-14 |
| APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 (K080125) | Wako Chemicals USA, Inc. | 2008-07-18 |
| HDL CHOLESTEROL REAGENT, MODEL 10211 (K073497) | Medica Corp. | 2008-04-14 |
| DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS (K072395) | Diazyme Laboratories | 2008-01-03 |
Recalls involving this device
No recalls on record reference this clearance.