510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981829Substantially Equivalent

Is Ebv-Ebna-1 Igg Elisa Test System

Diamedix Corp., Columbia MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981829 is the FDA 510(k) clearance record for IS EBV-EBNA-1 IGG ELISA TEST SYSTEM, a class I device, cleared for Diamedix Corp. on under FDA product code GNP (Antiserum, Cf, Epstein-Barr Virus). FDA records list 68 510(k) clearances for Diamedix Corp., from to . As of , FDA records show no recalls naming K981829.

Clearance record

Decision date
Received
(270 days to decision)
Product code
GNP Antiserum, Cf, Epstein-Barr Virus
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Diamedix Corp. 8775 M Centre Park Dr., Columbia MD
510(k) summary
Summary
Third party review
No

Clearances, product code GNP

Trailing 12 months

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

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