510(k) K994388
K994388 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "XE CHECK". The FDA issued a decision of Substantially Equivalent on January 14, 2000. The device falls under product code GLQ (Mixture, Control, White-Cell And Red-Cell Indices), 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
- January 14, 2000
- Date Received
- December 28, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixture, Control, White-Cell And Red-Cell Indices
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type