510(k) K931825
K931825 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "CD-CHEX CD4 LOW". The FDA issued a decision of Substantially Equivalent on June 6, 1994. The device falls under product code GGL (Control, White-Cell), a Class II device regulated under 21 CFR 864.8625. Streck Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 1994
- Date Received
- April 6, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, White-Cell
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type