AUTOGROUPER 16C SYS AUTOMATED REAG
FDA 510(k) clearance K834149 · decided 1984-03-09
Clearance details
- K-number
- K834149
- Device name
- AUTOGROUPER 16C SYS AUTOMATED REAG
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-12-01
- Decision date
- 1984-03-09
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- GMQ
- Device class
- 2
- Regulation number
- 866.3820
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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.