FORMALIN-ACETO-ALCOHOL FIXATIVE
FDA 510(k) clearance K842731 · decided 1984-09-11
Clearance details
- K-number
- K842731
- Device name
- FORMALIN-ACETO-ALCOHOL FIXATIVE
- Applicant
- E K Ind., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-13
- Decision date
- 1984-09-11
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- IGF
- Device class
- 1
- Regulation number
- 864.4010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch E K Ind.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.