The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Lh-30 Assay, Lan.0082/2082 240/144 Test.
Device ID | K880933 |
510k Number | K880933 |
Device Name: | AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST |
Classification | Radioimmunoassay, Luteinizing Hormone |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Jan L Zorn |
Correspondent | Jan L Zorn AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Product Code | CEP |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-07 |
Decision Date | 1988-07-28 |