510(k) K790958

120 WELL HISTO-PLATE by Dynatech Laboratories, Inc. — Product Code KIZ

K790958 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "120 WELL HISTO-PLATE". The FDA issued a decision of Substantially Equivalent on June 28, 1979. The device falls under product code KIZ (Dish, Tissue Culture), a Class I device regulated under 21 CFR 864.2240. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1979
Date Received
May 22, 1979
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