Atlas FDA

VITROS Chemistry Products PHBR Slides

FDA 510(k) clearance K210858 · decided 2021-08-13

Clearance details

K-number
K210858
Device name
VITROS Chemistry Products PHBR Slides
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2021-03-23
Decision date
2021-08-13
Days to decision
143 days
Clearance type
Traditional
Product code
DLZ
Device class
2
Regulation number
862.3660
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Rochester, NY, US
Third-party review
No
Expedited review
No

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RecordFirmDate
ABBOTT PHENOBARBITAL ASSAY (K123271)Microgenics Corp.2013-04-26
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RANDOX PHENOBARBITAL (K011303)Randox Laboratories, Ltd.2001-07-02
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (K011528)Syva Co.2001-06-06
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 (K000012)Diagnostic Products Corp.2000-03-03
ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 (K993031)Syva Co.2000-01-27
VITROS CHEMISTRY PRODUCTS PHBR SLIDES (K984288)Ortho-Clinical Diagnostics, Inc.1999-01-26
PHENOBARBITAL ENZYME IMMUNOASSAY (K946210)Diagnostic Reagents, Inc.1995-02-10
IL TEST PHENOBARBITAL CALIBRATORS (K943981)Instrumentation Laboratory CO1995-01-18
PHENOBARBITAL FLEX REAGENT CARTRIDGE (K944932)Dupont Medical Products1994-12-28
ACE CEDIA PHENOBARBITAL ASSAY (K942501)Schiapparelli Biosystems, Inc.1994-10-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITROS Anti-HBc IgM (P030026/S037)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018)Ortho-Clinical Diagnostics, Inc.2023-01-24
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036)Ortho-Clinical Diagnostics, Inc.2020-10-22
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033)Ortho-Clinical Diagnostics, Inc.2020-08-07
VITROS Anti-HBs (P000014/S035)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS Anti-HBc IgM (P030026/S036)Ortho-Clinical Diagnostics, Inc.2019-06-19
VITROS HBeAg (P090028/S017)Ortho-Clinical Diagnostics, Inc.2019-06-19