510(k) K041927
- Device
- LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
- Applicant
- Diagnostic Chemicals , Ltd.
- 510(k) number
- K041927
- Product code
- MRR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-11-23
- Date received
- 2004-07-19
- 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
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- NANCY OLSCAMP
- Address
- 16 Mccarville St. Charlottetown, P.E. CA C1E 2A6 C1E 2A6
FDA Registration Numbers#
- 3013660430
- 8020316
- 3006198300
- 3003795116
- 2030861
- 2050012
- 3003539867
- 3003522182
- 2432235
- 9610529
- 3012963943
- 2250051
- 1832216
- 1319808
- 3003419906
- 2517506
- 2247288
- 3007662974
- 1827821
- 3003356736
- 3004493545
- 3002642396
- 2050010
- 3010825766
- 3010891909
- 2085064
- 3003871639
- 3014325803
- 1616487
- 9610126
- 1220972
- 1319681
- 3011080315
- 3021841051
- 3000308930
- 3017379203
- 3006716639
- 3000148879
Source Documents#
510(k) summary PDF not indicated by FDA
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