Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

LJZ — Predicate Candidate Screening

13 FDA 510(k) clearances under this product code; the 50 most recent screened below.

152 daysmedian FDA review time

362 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K984153	THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELIS	Zeus Scientific, Inc.	1999-01-11	53
K971503	MYCOPLASMA IGM ELISA TEST SYSTEM	Zeus Scientific, Inc.	1997-08-20	118
K971393	MYCOPLASMA IGG ELISA TEST SYSTEM	Immunoprobe, Inc.	1997-07-14	96
K970150	MYCOPLASMA IGG ELISA TEST SYSTEM	Zeus Scientific, Inc.	1997-06-16	152
K963054	IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)	Genbio	1997-05-05	272
K963055	IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120	Genbio	1997-05-02	269
K934550	IMMUNOCARD MYCOPLASMA	Meridian Diagnostics, Inc.	1994-09-20	363
K920212	MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM	Shared Systems, Inc.	1992-08-20	217
K921556	MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM	Medical Diagnostic Technologies, Inc.	1992-06-29	89
K904501	MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM	Medical Diagnostic Technologies, Inc.	1991-02-26	147
K895276	DIATECH IGM-MP TEST	Diatech Diagnostica , Ltd.	1989-12-18	117
K882596	MP TEST	Diatech Diagnostica , Ltd.	1989-06-21	362
K823804	MYCOPLASMELISA TEST KIT	M.A. Bioproducts	1983-05-25	159

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda