510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K853453Substantially Equivalent

Bio Automed Sys Chemistry Analyzer Auto-Loader

Bio Automed Systems, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853453 is the FDA 510(k) clearance record for BIO AUTOMED SYS CHEMISTRY ANALYZER AUTO-LOADER, a class I device, cleared for Bio Automed Systems, Inc. on under FDA product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use). FDA records list one 510(k) clearance for Bio Automed Systems, Inc. As of , FDA records show no recalls naming K853453.

Clearance record

Decision date
Received
(45 days to decision)
Product code
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Regulation
21 CFR 862.2300
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bio Automed Systems, Inc. 485 Macara Ave. #903, Sunnyvale CA
Third party review
No

Clearances, product code JJQ

Trailing 12 months

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

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