510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823009Substantially Equivalent

Gamma Clq

Gamma Medical Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823009 is the FDA 510(k) clearance record for GAMMA CLQ, a class II device, cleared for Gamma Medical Products, Inc. on under FDA product code DAK (Complement C1q, Antigen, Antiserum, Control). FDA records list 2 510(k) clearances for Gamma Medical Products, Inc., from to . As of , FDA records show no recalls naming K823009.

Clearance record

Decision date
Received
(24 days to decision)
Product code
DAK Complement C1q, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
Device class
Class II
Review panel
Immunology
Applicant
Gamma Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DAK

Trailing 12 months

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

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