510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971909Substantially Equivalent

Virgo Ama Elisa Kit

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

K971909 is the FDA 510(k) clearance record for VIRGO AMA ELISA KIT, a class II device, cleared for Hemagen Diagnostics, Inc. on under FDA product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control). FDA records list 52 510(k) clearances for Hemagen Diagnostics, Inc., from to . As of , FDA records show no recalls naming K971909.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5090
Device class
Class II
Review panel
Immunology
Applicant
Hemagen Diagnostics, Inc. 34-40 Bear Hill Rd., Waltham MA
510(k) summary
Summary
Third party review
No

Clearances, product code DBM

Trailing 12 months

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

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