510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964781Substantially Equivalent

Immage Immunochemistry System Prealbumin (Pab) Reagent

Beckman Instruments, Inc., Brea CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964781 is the FDA 510(k) clearance record for IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT, a class I device, cleared for Beckman Instruments, Inc. on under FDA product code DDS (Prealbumin, Fitc, Antigen, Antiserum, Control). FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from to . As of , FDA records show no recalls naming K964781.

Clearance record

Decision date
Received
(163 days to decision)
Product code
DDS Prealbumin, Fitc, Antigen, Antiserum, Control
Regulation
21 CFR 866.5060
Device class
Class I
Review panel
Immunology
Applicant
Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337, Brea CA
510(k) summary
Summary
Third party review
No

Clearances, product code DDS

Trailing 12 months

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

FDA records show no clearances under product code DDS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DDS, 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