LACTI-QUANT
FDA 510(k) clearance K801849 · decided 1980-09-16
Clearance details
- K-number
- K801849
- Device name
- LACTI-QUANT
- Applicant
- Nuclear Medical Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-04
- Decision date
- 1980-09-16
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- CFT
- Device class
- 1
- Regulation number
- 862.1625
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nuclear Medical Laboratories
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.