QUICKSCREEN, MODELS 9177X AND 9178X
FDA 510(k) clearance K041578 · decided 2004-09-10
Clearance details
- K-number
- K041578
- Device name
- QUICKSCREEN, MODELS 9177X AND 9178X
- Applicant
- Phamatech
- Decision
- Substantially Equivalent
- Date received
- 2004-06-14
- Decision date
- 2004-09-10
- Days to decision
- 88 days
- Clearance type
- Special
- Product code
- LCM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- San Diego, CA, 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.
Recalls involving this device
No recalls on record reference this clearance.