AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
FDA 510(k) clearance K894310 · decided 1989-09-28
Clearance details
- K-number
- K894310
- Device name
- AMRESCO TRIGLYCERIDES REAGENTS (PRODUCTS 7730)
- Applicant
- American Research Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-14
- Decision date
- 1989-09-28
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- CDT
- Device class
- 1
- Regulation number
- 862.1705
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Solon, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.