The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Free T4 (2-step).
Device ID | K971792 |
510k Number | K971792 |
Device Name: | IMMULITE FREE T4 (2-STEP) |
Classification | Radioimmunoassay, Free Thyroxine |
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 | CEC |
CFR Regulation Number | 862.1695 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-15 |
Decision Date | 1997-07-25 |
Summary: | summary |