510(k) K810871
K810871 is an FDA 510(k) premarket notification submitted by Clintox Laboratories, Inc. for the device "LIGHTNING DIALYZER". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code DHY (Ng4m(A), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5065.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1981
- Date Received
- March 31, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ng4m(A), Antigen, Antiserum, Control
- Device Class
- Class I
- Regulation Number
- 866.5065
- Review Panel
- IM
- Submission Type