510(k) K803095
K803095 is an FDA 510(k) premarket notification submitted by Accra Laboratories, Inc. for the device "COPPER SULFATE SOLUTION SP. GR.1.055". The FDA issued a decision of Substantially Equivalent on March 6, 1981. The device falls under product code KSL (Solution, Copper Sulfate For Specific Gravity Determinations), a Class I device regulated under 21 CFR 864.9320. Accra Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1981
- Date Received
- December 8, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solution, Copper Sulfate For Specific Gravity Determinations
- Device Class
- Class I
- Regulation Number
- 864.9320
- Review Panel
- HE
- Submission Type