510(k) K894947
K894947 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "PLATELIA TOXO IGG KIT". The FDA issued a decision of Substantially Equivalent on March 23, 1990. The device falls under product code LGO (Test, Leukocyte Typing), a Class I device regulated under 21 CFR 864.7675. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1990
- Date Received
- August 3, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Leukocyte Typing
- Device Class
- Class I
- Regulation Number
- 864.7675
- Review Panel
- HE
- Submission Type