510(k) K823859
K823859 is an FDA 510(k) premarket notification submitted by Gibco Laboratories Life Technologies, Inc. for the device "MIDDLEBROOK 7H10 AGAR BASE-LOWPH". The FDA issued a decision of Substantially Equivalent on March 8, 1983. The device falls under product code MJD (Culture Media, Antimycobacteria, Susceptibility Test), a Class II device regulated under 21 CFR 866.1700. Gibco Laboratories Life Technologies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1983
- Date Received
- December 22, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Antimycobacteria, Susceptibility Test
- Device Class
- Class II
- Regulation Number
- 866.1700
- Review Panel
- MI
- Submission Type