The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Fsh Assay, Lan.0077/2077 240 And 144 Test.
Device ID | K881142 |
510k Number | K881142 |
Device Name: | AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Frank J Lyman |
Correspondent | Frank J Lyman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Product Code | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-17 |
Decision Date | 1988-07-21 |