510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945271Substantially Equivalent

Atac 8000 Random Access Chemistry System

Bio-Chem Laboratory Systems, Inc., Lakewood NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945271 is the FDA 510(k) clearance record for ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM, a class I device, cleared for Bio-Chem Laboratory Systems, Inc. on under FDA product code JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use). FDA records list 5 510(k) clearances for Bio-Chem Laboratory Systems, Inc., from to . As of , FDA records show one recall naming K945271.

Clearance record

Decision date
Received
(184 days to decision)
Product code
JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation
21 CFR 862.2160
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bio-Chem Laboratory Systems, Inc. 195 Lehigh Ave., Lakewood NJ
510(k) summary
Statement
Third party review
No

Clearances, product code JJE

Trailing 12 months

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

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