CODE QAS.105 PROLACTIN CONTROL SERA

Single (specified) Analyte Controls (assayed And Unassayed)

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Code Qas.105 Prolactin Control Sera.

Pre-market Notification Details

Device IDK800708
510k NumberK800708
Device Name:CODE QAS.105 PROLACTIN CONTROL SERA
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-03-31
Decision Date1980-04-16

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