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510(k) K885094

BIOTROL ALBUMIN by Biotrol, USA, Inc. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1989
Date Received
December 9, 1988
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

Other clearances by Biotrol, USA, Inc.

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  • K921855 — BIOTROL BICARBONATE STANDARDS (August 3, 1992)
  • K921677 — BIOTROL MAGNESIUM (MAGON) (May 26, 1992)
  • K912795 — BIOTROL UIBC REAGENT (August 12, 1991)
  • K910721 — BIOTROL PROTEIN MULTILEVEL STANDARDS (May 6, 1991)
  • K905683 — BIOTROL LACTATE DEHYDROGENASE (L-P) (March 11, 1991)
  • K905280 — BIOTROL BILIRUBIN C & T CONTROL (February 4, 1991)
  • K894544 — BIOTROL RUB-E.I.A. TEST G (August 30, 1989)
  • K891061 — BIOTROL CALCIUM MONOREACTIF (August 10, 1989)

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