510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894411Substantially Equivalent

Seratest Ena [Scl-70] Kit

Hemagen Diagnostics, Inc., Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894411 is the FDA 510(k) clearance record for SERATEST ENA [SCL-70] KIT, a class II device, cleared for Hemagen Diagnostics, Inc. on under FDA product code LKJ (Antinuclear Antibody, Antigen, Control). FDA records list 52 510(k) clearances for Hemagen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K894411.

Clearance record

Decision date
Received
(16 days to decision)
Product code
LKJ Antinuclear Antibody, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Hemagen Diagnostics, Inc. 34 Bear Hill Rd., Waltham MA
Third party review
No

Clearances, product code LKJ

Trailing 12 months

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

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