510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K851945Substantially Equivalent

Varian Aasp Automated Sample Prep. System

Varian Assoc., Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851945 is the FDA 510(k) clearance record for VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM, a class I device, cleared for Varian Assoc., Inc. on under FDA product code KZR (Chromatography (Liquid, Gel), Clinical Use). FDA records list 86 510(k) clearances for Varian Assoc., Inc., from to . As of , FDA records show no recalls naming K851945.

Clearance record

Decision date
Received
(21 days to decision)
Product code
KZR Chromatography (Liquid, Gel), Clinical Use
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Varian Assoc., Inc. 611 Hansen Way, Palo Alto CA
Third party review
No

Clearances, product code KZR

Trailing 12 months

FDA records hold no clearances under product code KZR in the trailing twelve months.

FDA records show no clearances under product code KZR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260