510(k) K873975
K873975 is an FDA 510(k) premarket notification submitted by Lakewood Biochemical Co., Inc. for the device "PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323". The FDA issued a decision of Substantially Equivalent on October 23, 1987. The device falls under product code JSJ (Culture Media, Selective And Non-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
- October 23, 1987
- Date Received
- September 29, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Culture Media, Selective And Non-Differential
- Device Class
- Class I
- Regulation Number
- 866.2360
- Review Panel
- MI
- Submission Type