510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780250Substantially Equivalent

Hemopexin Nephelometric Assays

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

K780250 is the FDA 510(k) clearance record for HEMOPEXIN NEPHELOMETRIC ASSAYS, a class II device, cleared for Kallestad Laboratories, Inc. on under FDA product code CZX (Hemopexin, Antigen, Antiserum, Control). FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K780250.

Clearance record

Decision date
Received
(14 days to decision)
Product code
CZX Hemopexin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5490
Device class
Class II
Review panel
Immunology
Applicant
Kallestad Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CZX

Trailing 12 months

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

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