510(k) K844369

BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO by Precision Dynamics Corp. — Product Code JSM

K844369 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "BBL PORT-A-CUL 21628 DOUBLE SWAB SULTURE COLLECTIO". The FDA issued a decision of Substantially Equivalent on January 4, 1985. The device falls under product code JSM (Culture Media, Non-Propagating Transport), a Class I device regulated under 21 CFR 866.2390. Precision Dynamics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1985
Date Received
November 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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