The following data is part of a premarket notification filed by Cyberfluor, Inc. with the FDA for Fiagen(tm) Hlh.s.
Device ID | K900621 |
510k Number | K900621 |
Device Name: | FIAGEN(TM) HLH.S |
Classification | Radioimmunoassay, Luteinizing Hormone |
Applicant | CYBERFLUOR, INC. 179 JOHN ST., 4TH FL., TORONTO Ontario M5t 1x4, CA |
Contact | James Clelland |
Correspondent | James Clelland CYBERFLUOR, INC. 179 JOHN ST., 4TH FL., TORONTO Ontario M5t 1x4, CA |
Product Code | CEP |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-08 |
Decision Date | 1990-03-01 |