510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010301Substantially Equivalent

Immunowell Ea (D) Igg Test

Genbio, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010301 is the FDA 510(k) clearance record for IMMUNOWELL EA (D) IGG TEST, a class I device, cleared for Genbio on under FDA product code LSE (Epstein-Barr Virus, Other). FDA records list 10 510(k) clearances for Genbio, from to . As of , FDA records show no recalls naming K010301.

Clearance record

Decision date
Received
(130 days to decision)
Product code
LSE Epstein-Barr Virus, Other
Regulation
21 CFR 866.3235
Device class
Class I
Review panel
Microbiology
Applicant
Genbio 15222 Ave. Of Science, San Diego CA
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