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
K211707Substantially Equivalent

BioTeke Sterile Disposable Virus Sampling Kit

Bioteke Corporation (Wuxi) Co., Ltd, Wuxi City, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211707 is the FDA 510(k) clearance record for BioTeke Sterile Disposable Virus Sampling Kit, a class I device, cleared for Bioteke Corporation (Wuxi) Co., Ltd. on under FDA product code JSM (Culture Media, Non-Propagating Transport). FDA records list one 510(k) clearance for Bioteke Corporation (Wuxi) Co., Ltd. As of , FDA records show no recalls naming K211707.

Clearance record

Decision date
Received
(335 days to decision)
Product code
JSM Culture Media, Non-Propagating Transport
Regulation
21 CFR 866.2390
Device class
Class I
Review panel
Microbiology
Applicant
Bioteke Corporation (Wuxi) Co., Ltd. 4th Floor, D5, # 1719, Huishan Ave., Wuxi City, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JSM

Trailing 12 months
1 clearance under product code JSM in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JSM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260