510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K770830Substantially Equivalent

Platelet Agitator

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

K770830 is the FDA 510(k) clearance record for PLATELET AGITATOR, a class I device, cleared for Helmer Labs, Inc. on under FDA product code GLE (Mixer, Blood Tube). FDA records list 3 510(k) clearances for Helmer Labs, Inc., from to . As of , FDA records show no recalls naming K770830.

Clearance record

Decision date
Received
(66 days to decision)
Product code
GLE Mixer, Blood Tube
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Helmer Labs, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GLE

Trailing 12 months

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

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