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510(k) K853049

ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE by Simmler, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1985
Date Received
July 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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  • K874812 — MULTICHEM CHLORIDE REAGENT S0933 (December 18, 1987)
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  • K874049 — MULTICHEM ALBUMIN REAGENT S0902 (October 29, 1987)
  • K874038 — MULTICHEM INORGANIC PHOSPHOROUS S0923 (October 28, 1987)
  • K873725 — MULTICHEM CREATININE REAGENT S0917 (October 20, 1987)
  • K873761 — MULTICHEM ALKALINE PHOSPHATASE (S0903) (October 7, 1987)

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