510(k) K862425
K862425 is an FDA 510(k) premarket notification submitted by Gibco Laboratories Life Technologies, Inc. for the device "MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM". The FDA issued a decision of Substantially Equivalent on July 2, 1986. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Gibco Laboratories Life Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1986
- Date Received
- June 26, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Selective And Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type