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510(k) K884035

SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER by Sclavo, Inc. — Product Code JJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1988
Date Received
September 23, 1988
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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  • K895822 — TOTAL BILIRUBIN L.F. (November 14, 1989)
  • K895847 — CREATININE 340 (ENZYMATIC) (October 30, 1989)
  • K880199 — CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K880049 — CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K873496 — ATYPICAL CHOLINESTERASE (January 27, 1989)
  • K884649 — TOTAL IRON BINDING CAPACITY TEST (December 14, 1988)

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