510(k) K961755

CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM by Proteins Intl., Inc. — Product Code JSN

K961755 is an FDA 510(k) premarket notification submitted by Proteins Intl., Inc. for the device "CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM". The FDA issued a decision of Substantially Equivalent on May 17, 1996. The device falls under product code JSN (Culture Media, Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Proteins Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1996
Date Received
May 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Propagating Transport
Device Class
Class I
Regulation Number
866.2390
Review Panel
MI
Submission Type