510(k) K832771
K832771 is an FDA 510(k) premarket notification submitted by Bio-Analytics Laboratories, Inc. for the device "ERYTHROCYTE TEST". The FDA issued a decision of Substantially Equivalent on October 28, 1983. The device falls under product code LKZ (Red-Cell Count By Photometry), a Class II device regulated under 21 CFR 864.7100. Bio-Analytics Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1983
- Date Received
- August 16, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Red-Cell Count By Photometry
- Device Class
- Class II
- Regulation Number
- 864.7100
- Review Panel
- HE
- Submission Type