LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
FDA 510(k) clearance K041927 · decided 2004-11-23
Clearance details
- K-number
- K041927
- Device name
- LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
- Applicant
- Diagnostic Chemicals , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-19
- Decision date
- 2004-11-23
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- MRR
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Charlottetown, P.E., CA
- Third-party review
- No
- Expedited review
- No
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| RAICHEM LDL-CHOLESTEROL DIRECT REAGENT (K022772) | Hemagen Diagnostics, Inc. | 2002-09-17 |
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Recalls involving this device
No recalls on record reference this clearance.