Atlas FDA

VITROS CHEMISTRY PRODUCTS PHBR SLIDES

FDA 510(k) clearance K984288 · decided 1999-01-26

Clearance details

K-number
K984288
Device name
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
Applicant
Ortho-Clinical Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1998-12-01
Decision date
1999-01-26
Days to decision
56 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

+ Add to Predicate Builder ◉ Watch Ortho-Clinical Diagnostics

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
VITROS Chemistry Products PHBR Slides (K210858)Ortho-Clinical Diagnostics, Inc.2021-08-13
ABBOTT PHENOBARBITAL ASSAY (K123271)Microgenics Corp.2013-04-26
ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 (K081231)Abbott Laboratories2008-09-26
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 (K071644)Roche Diagnostics Corp.2007-09-12
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
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

RecordFirmDate
VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog number 8221384 VI recall (Z-0319-2014)Ortho-Clinical Diagnostics2013-11-15
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative recall (Z-1152-2013)Ortho-Clinical Diagnostics2013-04-19
VITROS Chemistry Products PHBR Slides, REF 822 1384 --- COMMON/USUAL NAME: VITROS PHBR (Ph recall (Z-1117-2012)Ortho-Clinical Diagnostics2012-02-28

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