510(k) K884993
K884993 is an FDA 510(k) premarket notification submitted by Diagnostic Systems for the device "VISUAL BLOOD GLUCOSE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on December 29, 1988. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Diagnostic Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1988
- Date Received
- December 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Oxidase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type