CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS
FDA 510(k) clearance K922671 · decided 1992-08-11
Clearance details
- K-number
- K922671
- Device name
- CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS
- Applicant
- Nuccardiac Software, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-04
- Decision date
- 1992-08-11
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Torba Linda, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nuccardiac Software
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.