510(k) K852578
K852578 is an FDA 510(k) premarket notification submitted by American Laboratory Supply, Inc. for the device "CLED AGAR". The FDA issued a decision of Substantially Equivalent on Jul 12, 1985. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. American Laboratory Supply, Inc. has 35 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 12, 1985
- Date Received
- Jun 18, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Culture Media, Non-Selective And Differential
- Device Class
- Class I
- Regulation Number
- 866.2320
- Review Panel
- MI
- Submission Type
- 510(k) Exempt