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510(k) K831649

THERMOMIXER S213-PHOTOANALYZER S263 by Texas Intl. Laboratories, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device Class
Class I
Regulation Number
862.2160
Review Panel
CH
Submission Type

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  • K900684 — RDW AND MPV INDICES ON HEMAT 12 (April 16, 1990)
  • K884006 — HEMAT 12 (December 5, 1988)
  • K883177 — H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER (November 30, 1988)
  • K853722 — PLT-4 PLATELET ANALYZER (January 17, 1986)
  • K832886 — FLAME PHOTOMETER T281-T282-T283 (December 8, 1983)
  • K832890 — HEMACOMP 7 OR HEMATIL 7 (October 19, 1983)

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