AUTOPAK TSH MONOCLONAL IRMA KIT
FDA 510(k) clearance K870245 · decided 1987-04-01
Clearance details
- K-number
- K870245
- Device name
- AUTOPAK TSH MONOCLONAL IRMA KIT
- Applicant
- Micromedic Systems
- Decision
- Substantially Equivalent
- Date received
- 1987-01-21
- Decision date
- 1987-04-01
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- JLW
- Device class
- 2
- Regulation number
- 862.1690
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Horsham, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.