SYPH-TRUST
FDA 510(k) clearance K863368 · decided 1986-12-12
Clearance details
- K-number
- K863368
- Device name
- SYPH-TRUST
- Applicant
- I.A.F. Production, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-03
- Decision date
- 1986-12-12
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- GMQ
- Device class
- 2
- Regulation number
- 866.3820
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Quebec, Canada H7n4z9, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.