The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Acth Irma.
Device ID | K940271 |
510k Number | K940271 |
Device Name: | INCSTAR ACTH IRMA |
Classification | Radioimmunoassay, Acth |
Applicant | INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Contact | Mary Ellen Best |
Correspondent | Mary Ellen Best INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater, MN 55082 -0285 |
Product Code | CKG |
CFR Regulation Number | 862.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-21 |
Decision Date | 1994-08-02 |