QUANTIFY(901)
FDA 510(k) clearance K972710 · decided 1997-08-15
Clearance details
- K-number
- K972710
- Device name
- QUANTIFY(901)
- Applicant
- Hematronix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-21
- Decision date
- 1997-08-15
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Benicia, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.