510(k) K023483
K023483 is an FDA 510(k) premarket notification submitted by Inbios Intl., Inc. for the device "KALAZAR DETECT". The FDA issued a decision of Substantially Equivalent on May 6, 2003. The device falls under product code LOO (Reagent, Leishmanii Serological), a Class I device regulated under 21 CFR 866.3870. Inbios Intl., Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2003
- Date Received
- October 17, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Leishmanii Serological
- Device Class
- Class I
- Regulation Number
- 866.3870
- Review Panel
- MI
- Submission Type