LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
FDA 510(k) clearance DEN050002 · decided 2005-05-19
Clearance details
- K-number
- DEN050002
- Device name
- LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS
- Applicant
- Wako Chemicals USA, Inc.
- Decision
- Unknown
- Date received
- 2005-04-07
- Decision date
- 2005-05-19
- Days to decision
- 42 days
- Clearance type
- Post-NSE
- Product code
- NSF
- Device class
- 2
- Regulation number
- 866.6030
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Richmond, VA, 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 |
|---|---|---|
| UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION (K100464) | Wako Chemicals USA, Inc. | 2011-02-23 |
Recalls involving this device
No recalls on record reference this clearance.