ASSAYED CHOLINESTERASE CONTROL
FDA 510(k) clearance K885282 · decided 1989-06-09
Clearance details
- K-number
- K885282
- Device name
- ASSAYED CHOLINESTERASE CONTROL
- Applicant
- Actio, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-20
- Decision date
- 1989-06-09
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Oakland, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.