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510(k) K830641

ENCORE CHEMISTRY ANALYZER by Baker Instructions Corp. — Product Code JJG

K830641 is an FDA 510(k) premarket notification submitted by Baker Instructions Corp. for the device "ENCORE CHEMISTRY ANALYZER". The FDA issued a decision of Substantially Equivalent on April 5, 1983. The device falls under product code JJG (Analyzer, Chemistry, Centrifugal, For Clinical Use), a Class I device regulated under 21 CFR 862.2140. Baker Instructions Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
March 1, 1983
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 by Baker Instructions Corp.

  • K882612 — SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER (September 7, 1988)
  • K873596 — BAKER TDM THEOPHYLLINE ASSAY (October 20, 1987)
  • K870603 — SYSTEM 9000 AUTOMATED CELL COUNTER (March 31, 1987)
  • K854173 — UCD URINE SPECIMEN COLLECTOR (November 4, 1985)
  • K850386 — SYSTEM 8000 CELL COUNTER (May 2, 1985)
  • K833116 — SPIRIT CHEMISTRY SYSTEM (November 7, 1983)
  • K832716 — ENCORE CHEMISTRY ANALYZER (October 4, 1983)
  • K821956 — HAEM-C PLUS BLOOD REFERENCE CONTROLS (July 30, 1982)
  • K811694 — CENTRIFICHEM ALT/AGPT OPTIMIZED REAGENT (July 1, 1981)

Other clearances for product code JJG

  • K972409 — AG CHEMISTRY ANALYZER SYSTEM (August 28, 1997)
  • K942782 — PICCOLO(TM) (March 13, 1995)
  • 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)

FDA data resources