510(k) K896378
K896378 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "LYME-CHECK(TM) TEST KIT". The FDA issued a decision of Substantially Equivalent on November 5, 1991. The device falls under product code LSR (Reagent, Borrelia Serological Reagent), a Class II device regulated under 21 CFR 866.3830. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1991
- Date Received
- November 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent, Borrelia Serological Reagent
- Device Class
- Class II
- Regulation Number
- 866.3830
- Review Panel
- MI
- Submission Type