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
K961544Substantially Equivalent

Qualitrol Igame Controls, Levels 1 and 2

Consolidated Technologies, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961544 is the FDA 510(k) clearance record for QUALITROL IGAME CONTROLS, LEVELS 1 AND 2, a class I device, cleared for Consolidated Technologies, Inc. on under FDA product code DGR (Whole Human Serum, Antigen, Antiserum, Control). FDA records list 20 510(k) clearances for Consolidated Technologies, Inc., from to . As of , FDA records show no recalls naming K961544.

Clearance record

Decision date
Received
(155 days to decision)
Product code
DGR Whole Human Serum, Antigen, Antiserum, Control
Regulation
21 CFR 866.5700
Device class
Class I
Review panel
Immunology
Applicant
Consolidated Technologies, Inc. 2170 Woodward St., Suite 100, Austin TX
510(k) summary
Statement
Third party review
No

Clearances, product code DGR

Trailing 12 months

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

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