Quality Control Kits For Blood Banking Reagents

Kit, Quality Control For Blood Banking Reagents

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Quality Control Kits For Blood Banking Reagents.

Pre-market Notification Details

Device IDBK890021
510k NumberBK890021
Device Name:Quality Control Kits For Blood Banking Reagents
ClassificationKit, Quality Control For Blood Banking Reagents
Applicant Ortho-Clinical Diagnostics, Inc. 1001 U.s. Highway 202 Raritan,  NJ  08869 US
Product CodeKSF  
CFR Regulation Number864.9650 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-12
Decision Date1989-10-23

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