510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981496Substantially Equivalent

Color-Slide RF

Seradyn, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981496 is the FDA 510(k) clearance record for COLOR-SLIDE RF, a class II device, cleared for Seradyn, Inc. on under FDA product code DHR (System, Test, Rheumatoid Factor). FDA records list 30 510(k) clearances for Seradyn, Inc., from to . As of , FDA records show no recalls naming K981496.

Clearance record

Decision date
Received
(49 days to decision)
Product code
DHR System, Test, Rheumatoid Factor
Regulation
21 CFR 866.5775
Device class
Class II
Review panel
Immunology
Applicant
Seradyn, Inc. 1200 Madison Ave., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code DHR

Trailing 12 months

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

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