510(k) K900484
K900484 is an FDA 510(k) premarket notification submitted by Streck Laboratories, Inc. for the device "RET-CHECK". The FDA issued a decision of Substantially Equivalent on March 9, 1990. The device falls under product code GJR (Control, Red-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
- March 9, 1990
- Date Received
- February 1, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Red-Cell
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type