The following data is part of a premarket notification filed by Varian Assoc., Inc. with the FDA for Varian Aasp Automated Sample Prep. System.
Device ID | K851945 |
510k Number | K851945 |
Device Name: | VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM |
Classification | Chromatography (liquid, Gel), Clinical Use |
Applicant | VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
Contact | Milton D Diegel |
Correspondent | Milton D Diegel VARIAN ASSOC., INC. 611 HANSEN WAY P.O. BOX 10800 Palo Alto, CA 94303 |
Product Code | KZR |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-03 |
Decision Date | 1985-05-24 |