510(k) K792201
K792201 is an FDA 510(k) premarket notification submitted by Marion Health & Safety, Inc. for the device "STREP CULTURETTE". The FDA issued a decision of Substantially Equivalent on Nov 30, 1979. The device falls under product code JSN (Culture Media, 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
- Nov 30, 1979
- Date Received
- Nov 2, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Propagating Transport
- Device Class
- Class I
- Regulation Number
- 866.2390
- Review Panel
- MI
- Submission Type
- 510(k)