510(k) K871483

TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES by Isratech Marketing Corp. — Product Code KIZ

K871483 is an FDA 510(k) premarket notification submitted by Isratech Marketing Corp. for the device "TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES". The FDA issued a decision of Substantially Equivalent on April 29, 1987. The device falls under product code KIZ (Dish, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Isratech Marketing Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1987
Date Received
April 15, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dish, Tissue Culture
Device Class
Class I
Regulation Number
864.2240
Review Panel
PA
Submission Type