TECHNICON AUTOGROUPER 16-C SYSTEM
FDA 510(k) clearance K810899 · decided 1981-05-05
Clearance details
- K-number
- K810899
- Device name
- TECHNICON AUTOGROUPER 16-C SYSTEM
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-04-03
- Decision date
- 1981-05-05
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- KSZ
- Device class
- 2
- Regulation number
- 864.9175
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELDONCARD (K790282) | Nordisk Infuser System | 1979-05-04 |
| BLOOD GROUPING SYS., BG-9 (K771098) | Technicon Instruments Corp. | 1977-08-04 |
| RH CONTROL DILUENT (K770185) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-03-14 |
Recalls involving this device
No recalls on record reference this clearance.