The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Spq Pal Control Level Ii.
Device ID | K934966 |
510k Number | K934966 |
Device Name: | SPQ PAL CONTROL LEVEL II |
Classification | Prealbumin, Fitc, Antigen, Antiserum, Control |
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 | DDS |
CFR Regulation Number | 866.5060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-15 |
Decision Date | 1994-01-11 |