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510(k) K964409

HCL - 200 BIOCHEMISTRY ANALYZER by Hcl Laboratory Systems, Inc. — Product Code JJF

K964409 is an FDA 510(k) premarket notification submitted by Hcl Laboratory Systems, Inc. for the device "HCL - 200 BIOCHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on January 22, 1997. The device falls under product code JJF (Analyzer, Chemistry, Micro, For Clinical Use), a Class I device regulated under 21 CFR 862.2170.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1997
Date Received
November 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

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  • K973177 — MAGO AUTOMATED EIA PROCESSOR (October 9, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)

FDA data resources