510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780305Substantially Equivalent

Cell

Dynatech Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780305 is the FDA 510(k) clearance record for CELL, a class I device, cleared for Dynatech Laboratories, Inc. on under FDA product code KJF (System, Suspension, Cell Culture). FDA records list 44 510(k) clearances for Dynatech Laboratories, Inc., from to . As of , FDA records show no recalls naming K780305.

Clearance record

Decision date
Received
(32 days to decision)
Product code
KJF System, Suspension, Cell Culture
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Applicant
Dynatech Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KJF

Trailing 12 months

FDA records hold no clearances under product code KJF in the trailing twelve months.

FDA records show no clearances under product code KJF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KJF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260