510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K791049Substantially Equivalent

Synalon Roller Bottle

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

K791049 is the FDA 510(k) clearance record for SYNALON ROLLER BOTTLE, a class I device, cleared for Dynatech Laboratories, Inc. on under FDA product code KJC (Bottle, Roller, Tissue Culture). FDA records list 44 510(k) clearances for Dynatech Laboratories, Inc., from to . As of , FDA records show no recalls naming K791049.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KJC Bottle, Roller, Tissue 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 KJC

Trailing 12 months

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

FDA records show no clearances under product code KJC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KJC, 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