510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K964409Substantially Equivalent

Hcl - 200 Biochemistry Analyzer

Hcl Laboratory Systems, Inc., Escondido CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964409 is the FDA 510(k) clearance record for HCL - 200 BIOCHEMISTRY ANALYZER, a class I device, cleared for Hcl Laboratory Systems, Inc. on under FDA product code JJF (Analyzer, Chemistry, Micro, For Clinical Use). FDA records list one 510(k) clearance for Hcl Laboratory Systems, Inc. As of , FDA records show no recalls naming K964409.

Clearance record

Decision date
Received
(79 days to decision)
Product code
JJF Analyzer, Chemistry, Micro, For Clinical Use
Regulation
21 CFR 862.2170
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Hcl Laboratory Systems, Inc. 362 Camino Bailen, Escondido CA
510(k) summary
Summary
Third party review
No

Clearances, product code JJF

Trailing 12 months

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

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