TMC I, II
FDA 510(k) clearance K930534 · decided 1994-04-04
Clearance details
- K-number
- K930534
- Device name
- TMC I, II
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-02
- Decision date
- 1994-04-04
- Days to decision
- 426 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ciba Corning Diagnostics Corp.
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.