510(k) K840970

CULTURE MEDIUM FOR PATHOGENIC NEISSER by Chatham Biological — Product Code JTY

K840970 is an FDA 510(k) premarket notification submitted by Chatham Biological for the device "CULTURE MEDIUM FOR PATHOGENIC NEISSER". The FDA issued a decision of Substantially Equivalent on Apr 13, 1984. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Chatham Biological has 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 13, 1984
Date Received
Mar 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Culture Media, For Isolation Of Pathogenic Neisseria
Device Class
Class II
Regulation Number
866.2410
Review Panel
MI
Submission Type
510(k)

Source: FDA 510(k) database entry for K840970. Report a data issue: hello@regdatalab.com.