The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Code Qas.105 Prolactin Control Sera.
Device ID | K800708 |
510k Number | K800708 |
Device Name: | CODE QAS.105 PROLACTIN CONTROL SERA |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-31 |
Decision Date | 1980-04-16 |