510(k) K893562
K893562 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "A.QC HCT LEVEL 1 AND 2". The FDA issued a decision of Substantially Equivalent on July 14, 1989. The device falls under product code GLK (Control, Hematocrit), a Class II device regulated under 21 CFR 864.8625. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1989
- Date Received
- May 9, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Hematocrit
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type