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510(k) K972409

AG CHEMISTRY ANALYZER SYSTEM by Landmark Scientific, Inc. — Product Code JJG

K972409 is an FDA 510(k) premarket notification submitted by Landmark Scientific, Inc. for the device "AG CHEMISTRY ANALYZER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 28, 1997. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1997
Date Received
June 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Centrifugal, For Clinical Use
Device Class
Class I
Regulation Number
862.2140
Review Panel
CH
Submission Type

Other clearances for product code JJG

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  • K934592 — EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTOR (April 6, 1994)
  • K920942 — OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER (June 10, 1992)
  • K910222 — COBAS ALPHA (February 27, 1991)
  • K903626 — BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA (October 15, 1990)
  • K893854 — COBAS FARA II CENTRIFUGAL ANALYZER (August 3, 1989)
  • K893641 — COBAS FARA CENTRIFUGAL ANALYZER (July 20, 1989)
  • K885203 — TECHNICON DAX(TM) SYSTEM (March 28, 1989)
  • K871973 — IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. (June 11, 1987)
  • K871838 — BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (May 26, 1987)

FDA data resources