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510(k) K895943

NORMAL AND ABNORMAL CONTROL SERA by Sclavo, Inc. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1989
Date Received
October 11, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Sclavo, Inc.

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  • K895822 — TOTAL BILIRUBIN L.F. (November 14, 1989)
  • K895847 — CREATININE 340 (ENZYMATIC) (October 30, 1989)
  • K880049 — CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K880199 — CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K873496 — ATYPICAL CHOLINESTERASE (January 27, 1989)
  • K884035 — SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER (December 29, 1988)
  • K884649 — TOTAL IRON BINDING CAPACITY TEST (December 14, 1988)

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