510(k) K780506
K780506 is an FDA 510(k) premarket notification submitted by Gamma Enterprises, Inc. for the device "CARBON DIOXIDE REAGENTS". The FDA issued a decision of Substantially Equivalent on May 3, 1978. The device falls under product code KMS (Phenolphthalein Colorimetry, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Gamma Enterprises, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1978
- Date Received
- March 30, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phenolphthalein Colorimetry, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type