The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Ria Kit, Lh.
Device ID | K781685 |
510k Number | K781685 |
Device Name: | RIA KIT, LH |
Classification | Radioimmunoassay, Luteinizing Hormone |
Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CEP |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-04 |
Decision Date | 1978-10-27 |