510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963054Substantially Equivalent

Immunowell Mycoplasma Pneumonia Antibody (Igm) Test (3130)

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

K963054 is the FDA 510(k) clearance record for IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130), a class I device, cleared for Genbio on under FDA product code LJZ (Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.). FDA records list 10 510(k) clearances for Genbio, from to . As of , FDA records show no recalls naming K963054.

Clearance record

Decision date
Received
(272 days to decision)
Product code
LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Regulation
21 CFR 866.3375
Device class
Class I
Review panel
Microbiology
Applicant
Genbio 15222 Ave. Of Science, San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code LJZ

Trailing 12 months

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

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