The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Spq Malb Control Level Ii.
Device ID | K934521 |
510k Number | K934521 |
Device Name: | SPQ MALB CONTROL LEVEL II |
Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
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 | JJX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-17 |
Decision Date | 1993-11-26 |