Atlas FDA

IMMUNEX CRP

FDA 510(k) clearance K812881 · decided 1981-10-26

Clearance details

K-number
K812881
Device name
IMMUNEX CRP
Applicant
Armkel, LLC
Decision
Substantially Equivalent
Date received
1981-10-14
Decision date
1981-10-26
Days to decision
12 days
Clearance type
Traditional
Product code
DCN
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
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Tina-quant C-Reactive Protein IV (K192072)Roche Diagnostics Operations (Rdo)2020-02-21
Optilite High Sensitivity C-Reactive Protein Kit (K180099)The Binding Site Group , Ltd.2018-10-12
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls (K172868)The Binding Site Group , Ltd.2018-02-28
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (K171498)Meso Scale Diagnostics, LLC2018-01-12
C-Reactive Protein Kit for use on SPAPLUS (K161982)The Binding Site Group2017-04-05
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) (K113809)Hitachi Chemical Diagnostics, Inc.2012-08-17
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM (K091052)Abaxis, Inc.2010-01-15
C-REACTIVE PROTEIN (LATEX) (K083444)Roche Diagnostics Corp.2009-03-18
PATHFAST HSCRP (K083412)Mitsubishi Kagaku Iatron2009-03-09
S-TEST C-REACTIVE PROTEIN (CRP) (K083040)Alfa Wassermann Diagnostic Technologies, Inc.2009-01-30

Recalls involving this device

No recalls on record reference this clearance.