510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253358Substantially Equivalent

Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay

Diazyme Laboratories, Inc., Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253358 is the FDA 510(k) clearance record for Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay, a class II device, cleared for Diazyme Laboratories, Inc. on under FDA product code DFH (Kappa, Antigen, Antiserum, Control). FDA records list 52 510(k) clearances for Diazyme Laboratories, Inc., from to . As of , FDA records show no recalls naming K253358.

Clearance record

Decision date
Received
(80 days to decision)
Product code
DFH Kappa, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Applicant
Diazyme Laboratories, Inc. 12889 Gregg Ct., Poway CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DFH

Trailing 12 months
1 clearance under product code DFH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DFH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260