IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
FDA 510(k) clearance K060929 · decided 2006-04-28
Clearance details
- K-number
- K060929
- Device name
- IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
- Applicant
- Diagnostic Products Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-04-05
- Decision date
- 2006-04-28
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- CDD
- Device class
- 2
- Regulation number
- 862.1810
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Diagnostic Products Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.