510(k) K864313
K864313 is an FDA 510(k) premarket notification submitted by Hf Scientific, Inc. for the device "CO2 REAGENT SET". The FDA issued a decision of Substantially Equivalent on March 13, 1987. The device falls under product code CIE (Volumetric/Manometric, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Hf Scientific, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 1987
- Date Received
- November 3, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Volumetric/Manometric, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type