510(k) K850143

SPORDEX CULTURE MEDIA by American Sterilizer Co. — Product Code JSC

K850143 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "SPORDEX CULTURE MEDIA". The FDA issued a decision of Substantially Equivalent on Mar 5, 1985. The device falls under product code JSC (Culture Media, General Nutrient Broth), a Class I device regulated under 21 CFR 866.2350. American Sterilizer Co. has 35 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 5, 1985
Date Received
Jan 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Culture Media, General Nutrient Broth
Device Class
Class I
Regulation Number
866.2350
Review Panel
MI
Submission Type
510(k) Exempt

Source: FDA 510(k) database entry for K850143. Report a data issue: hello@regdatalab.com.