The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Dsl Active Prolactin Elisa Model 10-4500.
Device ID | K960561 |
510k Number | K960561 |
Device Name: | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 |
Classification | Radioimmunoassay, Prolactin (lactogen) |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | John Willis |
Correspondent | John Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | CFT |
CFR Regulation Number | 862.1625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-09 |
Decision Date | 1996-04-26 |