510(k) K813342
K813342 is an FDA 510(k) premarket notification submitted by Gamma Biologicals, Inc. for the device "GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION". The FDA issued a decision of Substantially Equivalent on March 4, 1982. The device falls under product code KSK (Solution, Stabilized Enzyme), a Class II device regulated under 21 CFR 864.9400. Gamma Biologicals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1982
- Date Received
- November 25, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solution, Stabilized Enzyme
- Device Class
- Class II
- Regulation Number
- 864.9400
- Review Panel
- HE
- Submission Type