510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K960997Substantially Equivalent

Starswab Culture Collection and Transport System

Starplex Scientific Corp., Etobicoke, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960997 is the FDA 510(k) clearance record for STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM, a class I device, cleared for Starplex Scientific, Inc. on under FDA product code LIO (Device, Specimen Collection). FDA records list 11 510(k) clearances for Starplex Scientific, Inc., from to . As of , FDA records show no recalls naming K960997.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Starplex Scientific, Inc. 50 Steinway Blvd., Etobicoke, Ontario, CA
510(k) summary
Summary
Third party review
No

Clearances, product code LIO

Trailing 12 months

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

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