510(k) K891370
K891370 is an FDA 510(k) premarket notification submitted by Elite Diagnostic , Ltd. for the device "EDL ONE-STAGE PROTHROMBIN TIME REAGENT". The FDA issued a decision of Substantially Equivalent on April 21, 1989. The device falls under product code GJS (Test, Time, Prothrombin), a Class II device regulated under 21 CFR 864.7750. Elite Diagnostic , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1989
- Date Received
- March 9, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Time, Prothrombin
- Device Class
- Class II
- Regulation Number
- 864.7750
- Review Panel
- HE
- Submission Type