Atlas FDA

LJZ

13 FDA 510(k) clearances · Product code

152 daysmedian time to decision
362 days90th percentile
13clearances measured

FDA profile

Official device name
Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3375
Medical specialty
Microbiology
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RecordFirmDate
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. (K984153)Zeus Scientific, Inc.1999-01-11
MYCOPLASMA IGM ELISA TEST SYSTEM (K971503)Zeus Scientific, Inc.1997-08-20
MYCOPLASMA IGG ELISA TEST SYSTEM (K971393)Immunoprobe, Inc.1997-07-14
MYCOPLASMA IGG ELISA TEST SYSTEM (K970150)Zeus Scientific, Inc.1997-06-16
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) (K963054)Genbio1997-05-05
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 (K963055)Genbio1997-05-02
IMMUNOCARD MYCOPLASMA (K934550)Meridian Diagnostics, Inc.1994-09-20
MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM (K920212)Shared Systems, Inc.1992-08-20
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM (K921556)Medical Diagnostic Technologies, Inc.1992-06-29
MYCOPLASMA PNEUMONIAE ANTIBODY TEST SYSTEM (K904501)Medical Diagnostic Technologies, Inc.1991-02-26
DIATECH IGM-MP TEST (K895276)Diatech Diagnostica , Ltd.1989-12-18
MP TEST (K882596)Diatech Diagnostica , Ltd.1989-06-21
MYCOPLASMELISA TEST KIT (K823804)M.A. Bioproducts1983-05-25

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Every clearance here is in the API, with alerts when new ones post.