Y-GLUTAMYLTRANSFERASE
FDA 510(k) clearance K813215 · decided 1981-12-08
Clearance details
- K-number
- K813215
- Device name
- Y-GLUTAMYLTRANSFERASE
- Applicant
- American Monitor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-11-09
- Decision date
- 1981-12-08
- Days to decision
- 29 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.