AMYLASE PROCEDURE
FDA 510(k) clearance K863588 · decided 1986-09-29
Clearance details
- K-number
- K863588
- Device name
- AMYLASE PROCEDURE
- Applicant
- Data Medical Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-15
- Decision date
- 1986-09-29
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- JFJ
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Arlington, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.