510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780544Substantially Equivalent

Disc-Pak Rotator

Techhnilab Instruments, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780544 is the FDA 510(k) clearance record for DISC-PAK ROTATOR, a class I device, cleared for Techhnilab Instruments, Inc. on under FDA product code GLE (Mixer, Blood Tube). FDA records list 6 510(k) clearances for Techhnilab Instruments, Inc., from to . As of , FDA records show no recalls naming K780544.

Clearance record

Decision date
Received
(21 days to decision)
Product code
GLE Mixer, Blood Tube
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Techhnilab Instruments, Inc. 4221 Richmond Rd., NW, Walker MI
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