TISSUE-TEK III TISSUE EMBEDDING CENTER
FDA 510(k) clearance K801956 · decided 1980-09-16
Clearance details
- K-number
- K801956
- Device name
- TISSUE-TEK III TISSUE EMBEDDING CENTER
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-08-18
- Decision date
- 1980-09-16
- Days to decision
- 29 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |