SICKLE HEMOGLOBIN (HBA/S) CONTROL SET

Control, Hemoglobin, Abnormal

CREATIVE LABORATORY PRODUCTS, INC.

The following data is part of a premarket notification filed by Creative Laboratory Products, Inc. with the FDA for Sickle Hemoglobin (hba/s) Control Set.

Pre-market Notification Details

Device IDK913427
510k NumberK913427
Device Name:SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
ClassificationControl, Hemoglobin, Abnormal
Applicant CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis,  IN  46268
ContactGary J Proksch
CorrespondentGary J Proksch
CREATIVE LABORATORY PRODUCTS, INC. 6258 LA PAS TRAIL Indianapolis,  IN  46268
Product CodeJCM  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-01
Decision Date1991-11-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.