SYSTEMATE 2GT - 67207
FDA 510(k) clearance K843268 · decided 1984-09-13
Clearance details
- K-number
- K843268
- Device name
- SYSTEMATE 2GT - 67207
- Applicant
- Em Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-20
- Decision date
- 1984-09-13
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JQB
- Device class
- 1
- Regulation number
- 862.1360
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.