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
K000718Substantially Equivalent

Chromostreak

Novamed Co., Ltd., Jerusalem, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000718 is the FDA 510(k) clearance record for CHROMOSTREAK, a class I device, cleared for Novamed , Ltd. on under FDA product code JSN (Culture Media, Propagating Transport). FDA records list 4 510(k) clearances for Novamed , Ltd., from to . As of , FDA records show no recalls naming K000718.

Clearance record

Decision date
Received
(174 days to decision)
Product code
JSN Culture Media, Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Novamed , Ltd. 28 Pierre Koenig St.,, Jerusalem, IL
510(k) summary
Summary
Third party review
No

Clearances, product code JSN

Trailing 12 months

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

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