The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Modified Dsl-2300 Acth Ria.
Device ID | K900147 |
510k Number | K900147 |
Device Name: | MODIFIED DSL-2300 ACTH RIA |
Classification | Radioimmunoassay, Acth |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Contact | Johnny R Willis |
Correspondent | Johnny R Willis DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster, TX 77598 |
Product Code | CKG |
CFR Regulation Number | 862.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-11 |
Decision Date | 1990-03-01 |