Atlas FDA

LEGIONELLA ELISA TEST SYSTEM

FDA 510(k) clearance K970149 · decided 1997-06-18

Clearance details

K-number
K970149
Device name
LEGIONELLA ELISA TEST SYSTEM
Applicant
Zeus Scientific, Inc.
Decision
Substantially Equivalent
Date received
1997-01-15
Decision date
1997-06-18
Days to decision
154 days
Clearance type
Traditional
Product code
LHL
Device class
2
Regulation number
866.3300
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Raritan, NJ, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E (K984123)Zeus Scientific, Inc.1999-01-11
LEGIONELLA IGG/IGM ELISA TEST SYSTEM (K963318)Armkel, LLC1997-03-03
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DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT (K871328)E.I. Dupont DE Nemours & Co., Inc.1987-09-02
LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST (K864006)Medical Diagnostic Technologies, Inc.1987-04-20
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO (K854108)Medical Diagnostic Technologies, Inc.1985-11-12
LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT (K852237)Genetic Systems Corp.1985-08-22
GENETIC SYS LEGIONELLA IMMUNOFLURORES (K842683)Genetic Systems Corp.1984-08-02
LEGIONELLA INDIRECT FLUORESCENT ANTIBOD (K832896)Biodan Medical Systems, Ltd.1983-10-14
LEGIONELLA IFA KIT I (K831760)Bionetic Laboratory Products1983-08-08
INDIRECT FLUORESCENT ANTIBODY REAGENTS (K831026)Zeus Technologies1983-06-22
LEGIONELLA DFA KIT I (K830820)Bionetic Laboratory Products1983-06-08

Recalls involving this device

RecordFirmDate
The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual co recall (Z-0541-05)Diamedix Corporation2005-02-15

PMA approvals by this applicant

RecordFirmDate
ZEUS ELISA PARVOVIRUS B19 IGM TEST SYSTEM (P150042)Zeus Scientific, Inc.2017-09-19
ZEUS ELISA PARVOVIRUS B19 IGG TEST SYSTEM (P150045)Zeus Scientific, Inc.2017-09-19
FLUORO-CEP (R) PROGESTERONE (P900025/S001)Zeus Scientific, Inc.1992-04-21
FLUORO-CEP (R) PROGESTERONE (P900025/S002)Zeus Scientific, Inc.1992-04-17
FLUORO-CEP (R) PROGESTERONE (P900025)Zeus Scientific, Inc.1990-09-26