510(k) K901875
K901875 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "PARA 12 PLUS". The FDA issued a decision of Substantially Equivalent on May 30, 1990. The device falls under product code JCN (Control, Cell Counter, Normal And Abnormal), 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
- May 30, 1990
- Date Received
- April 26, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Cell Counter, Normal And Abnormal
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type