510(k) K890819
K890819 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "HSV-CHECK(TM) TEST KIT". The FDA issued a decision of Substantially Equivalent on June 20, 1989. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 1989
- Date Received
- February 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type