ELECTRIC SELF STERILIZATION INOCUL. LOOP
FDA 510(k) clearance K813523 · decided 1981-12-31
Clearance details
- K-number
- K813523
- Device name
- ELECTRIC SELF STERILIZATION INOCUL. LOOP
- Applicant
- Techhnilab Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-16
- Decision date
- 1981-12-31
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LTB
- Device class
- 2
- Regulation number
- 862.1235
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Techhnilab Instruments
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.
Recalls involving this device
No recalls on record reference this clearance.