CB FORMALIN
FDA 510(k) clearance K842862 · decided 1984-08-28
Clearance details
- K-number
- K842862
- Device name
- CB FORMALIN
- Applicant
- Anatech, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-23
- Decision date
- 1984-08-28
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- IGE
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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 |
|---|---|---|
| SALINE SOLUTINE, STERILE (K950560) | Busse Hospital Disposables, Inc. | 1995-05-30 |
Recalls involving this device
No recalls on record reference this clearance.