The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Acth Normal Range.
Device ID | K842249 |
510k Number | K842249 |
Device Name: | ACTH NORMAL RANGE |
Classification | Radioimmunoassay, Acth |
Applicant | DIAGNOSTIC SYSTEMS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CKG |
CFR Regulation Number | 862.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-06 |
Decision Date | 1984-08-15 |