510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K790380Substantially Equivalent

Low-Tox-H Rabbit Complement

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

K790380 is the FDA 510(k) clearance record for LOW-TOX-H RABBIT COMPLEMENT, a class I device, cleared for Cederlane Labs , Ltd. on under FDA product code KTQ (Reagent, Complement). FDA records list one 510(k) clearance for Cederlane Labs , Ltd. As of , FDA records show no recalls naming K790380.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KTQ Reagent, Complement
Regulation
21 CFR 866.4100
Device class
Class I
Review panel
Immunology
Applicant
Cederlane Labs , Ltd. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KTQ

Trailing 12 months

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

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