510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862821Substantially Equivalent

Cappel Diagnostics Ana Kit

Cappel Diagnostics, Inc., Davis CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862821 is the FDA 510(k) clearance record for CAPPEL DIAGNOSTICS ANA KIT, a class II device, cleared for Cappel Diagnostics, Inc. on under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control). FDA records list 3 510(k) clearances for Cappel Diagnostics, Inc., from to . As of , FDA records show no recalls naming K862821.

Clearance record

Decision date
Received
(21 days to decision)
Product code
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
Cappel Diagnostics, Inc. P.O. Box 4027, Davis CA
Third party review
No

Clearances, product code DHN

Trailing 12 months

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

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