510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962499Substantially Equivalent

Zymmune Autoreader-F Fluorescence Microplate Reader

Bartels, Inc., Issaquah WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962499 is the FDA 510(k) clearance record for ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER, a class I device, cleared for Bartels, Inc. on under FDA product code JZT (Fluorometer). FDA records list 2 510(k) clearances for Bartels, Inc., from to . As of , FDA records show no recalls naming K962499.

Clearance record

Decision date
Received
(71 days to decision)
Product code
JZT Fluorometer
Regulation
21 CFR 866.4520
Device class
Class I
Review panel
Immunology
Applicant
Bartels, Inc. 2005 NW Sammamish Rd., #107, Issaquah WA
510(k) summary
Summary
Third party review
No

Clearances, product code JZT

Trailing 12 months

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

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