510(k) K800832
K800832 is an FDA 510(k) premarket notification submitted by Marion Health & Safety, Inc. for the device "VIRAL CULTURETTE HANK'S BAL. SALT SOL.". The FDA issued a decision of Substantially Equivalent on May 20, 1980. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Marion Health & Safety, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 1980
- Date Received
- Apr 14, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Non-Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type
- 510(k)