510(k) K992397
K992397 is an FDA 510(k) premarket notification submitted by Cenogenics Corp. for the device "ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE". The FDA issued a decision of Substantially Equivalent on August 26, 1999. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Cenogenics Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1999
- Date Received
- July 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Visual, Pregnancy Hcg, Prescription Use
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type