510(k) K971653
K971653 is an FDA 510(k) premarket notification submitted by Clinical Diagnostics, Inc. for the device "GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 2, 1998. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Clinical Diagnostics, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 1998
- Date Received
- May 6, 1997
- 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