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 |