510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K853261Substantially Equivalent

Laser Rbp Laser(retinol Binding Protein Reagents)

Behring Diagnostics, Inc., La Jolla CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853261 is the FDA 510(k) clearance record for LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS), a class I device, cleared for Behring Diagnostics, Inc. on under FDA product code CZS (Retinol-Binding Protein, Antigen, Antiserum, Control). FDA records list 145 510(k) clearances for Behring Diagnostics, Inc., from to . As of , FDA records show no recalls naming K853261.

Clearance record

Decision date
Received
(20 days to decision)
Product code
CZS Retinol-Binding Protein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5765
Device class
Class I
Review panel
Immunology
Applicant
Behring Diagnostics, Inc. 10933 No Torrey Pines Rd., La Jolla CA
Third party review
No

Clearances, product code CZS

Trailing 12 months

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

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