510(k) K873594
K873594 is an FDA 510(k) premarket notification submitted by Devetec, Inc. for the device "TIF FECAL TEST". The FDA issued a decision of Substantially Equivalent on September 29, 1987. The device falls under product code LEA (Preservative, Cytological), a Class I device regulated under 21 CFR 864.4010. Devetec, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1987
- Date Received
- September 4, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Preservative, Cytological
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type