The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Hgh.
Device ID | K955376 |
510k Number | K955376 |
Device Name: | IMMULITE HGH |
Classification | Radioimmunoassay, Human Growth Hormone |
Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
Contact | Edward M Levine |
Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
Product Code | CFL |
CFR Regulation Number | 862.1370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-24 |
Decision Date | 1996-02-16 |