510(k) K874344
K874344 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "QUAD PLATE (4 DIFFERENT MEDIA)". The FDA issued a decision of Substantially Equivalent on November 6, 1987. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. Lakewood Biochemical Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 1987
- Date Received
- October 20, 1987
- 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