510(k) K872507

PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II by Precision Dynamics Corp. — Product Code JSM

K872507 is an FDA 510(k) premarket notification submitted by Precision Dynamics Corp. for the device "PRECISION CULTURE C.A.T.S. COLLECT/TRANS HSV I/II". The FDA issued a decision of Substantially Equivalent on July 9, 1987. 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
July 9, 1987
Date Received
June 24, 1987
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