510(k) K953643
K953643 is an FDA 510(k) premarket notification submitted by Texas Intl. Laboratories, Inc. for the device "HEMATIL 18 (H-18)". The FDA issued a decision of Substantially Equivalent on March 22, 1996. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Texas Intl. Laboratories, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1996
- Date Received
- August 4, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter, Differential Cell
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type