510(k) K901597
K901597 is an FDA 510(k) premarket notification submitted by Intercare Diagnostics, Inc. for the device "INDX DIP S TICKS". The FDA issued a decision of Substantially Equivalent on December 21, 1990. The device falls under product code LSQ (Reagent, Rickettsia Serological), a Class I device regulated under 21 CFR 866.3500. Intercare Diagnostics, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1990
- Date Received
- April 5, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Rickettsia Serological
- Device Class
- Class I
- Regulation Number
- 866.3500
- Review Panel
- MI
- Submission Type