510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820246Substantially Equivalent

Prefilled Specimen Container

Sage Products LLC, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820246 is the FDA 510(k) clearance record for PREFILLED SPECIMEN CONTAINER, a class I device, cleared for Sage Products, Inc. on under FDA product code KDT (Container, Specimen Mailer And Storage, Sterile). FDA records list 31 510(k) clearances for Sage Products, Inc., from to . As of , FDA records show no recalls naming K820246.

Clearance record

Decision date
Received
(20 days to decision)
Product code
KDT Container, Specimen Mailer And Storage, Sterile
Regulation
21 CFR 864.3250
Device class
Class I
Review panel
Pathology
Applicant
Sage Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KDT

Trailing 12 months

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

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