OPTICOAT T4 EIA KIT
FDA 510(k) clearance K982298 · decided 1999-02-03
Clearance details
- K-number
- K982298
- Device name
- OPTICOAT T4 EIA KIT
- Applicant
- Biotecx Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-01
- Decision date
- 1999-02-03
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- KLI
- Device class
- 2
- Regulation number
- 862.1700
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.