510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830641Substantially Equivalent

Encore Chemistry Analyzer

Baker Instructions Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830641 is the FDA 510(k) clearance record for ENCORE CHEMISTRY ANALYZER, a class I device, cleared for Baker Instructions Corp. on under FDA product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use). FDA records list 10 510(k) clearances for Baker Instructions Corp., from to . As of , FDA records show no recalls naming K830641.

Clearance record

Decision date
Received
(35 days to decision)
Product code
JJG Analyzer, Chemistry, Centrifugal, For Clinical Use
Regulation
21 CFR 862.2140
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Baker Instructions Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJG

Trailing 12 months

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

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