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 |