BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set— 510(k) K170413

Clearance details

Applicant

Bio-Rad Laboratories

Product code

Code LIP

Device class

Class 2

Regulation

21 CFR 866.3830

Advisory panel

Microbiology

Date received

2017-02-10

Decision date

2017-05-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Benicia, CA, US

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• Z-0806-2022 — BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent PackClass II·Ongoing·Bio-Rad Laboratories, Inc.·20220208
• Z-0807-2022 — BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CALClass II·Ongoing·Bio-Rad Laboratories, Inc.·20220208
• Z-0235-2022 — BIO-RAD BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of nontreponemal reagin antibodies in human serum or plasmaClass II·Ongoing·Bio-Rad Laboratories, Inc.·20210917
• Z-0236-2022 — BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the calibration of the BioPlex 2200 Syphilis Total & RPR Reagent Pack.Class II·Ongoing·Bio-Rad Laboratories, Inc.·20210917
• Z-2982-2020 — BioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema pallidum:UDI:03610520653012 - Product Usage: intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma.Class II·Ongoing·Bio-Rad Laboratories, Inc.·20200421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170413.