510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K983842Substantially Equivalent

Biotest Anti-Ebv Recombinant, Ea Igm

Biotest Diagnostics Corp., Denville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983842 is the FDA 510(k) clearance record for BIOTEST ANTI-EBV RECOMBINANT, EA IGM, a class I device, cleared for Biotest Diagnostics Corp. on under FDA product code LSE (Epstein-Barr Virus, Other). FDA records list 5 510(k) clearances for Biotest Diagnostics Corp., from to . As of , FDA records show no recalls naming K983842.

Clearance record

Decision date
Received
(222 days to decision)
Product code
LSE Epstein-Barr Virus, Other
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Biotest Diagnostics Corp. 66 Ford Rd., Suite 131, Denville NJ
510(k) summary
Summary
Third party review
No

Clearances, product code LSE

Trailing 12 months

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

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