EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
FDA 510(k) clearance K890990 · decided 1989-04-10
Clearance details
- K-number
- K890990
- Device name
- EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
- Applicant
- Hichem Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1989-02-27
- Decision date
- 1989-04-10
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- CHH
- Device class
- 1
- Regulation number
- 862.1175
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.