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510(k) K905280

BIOTROL BILIRUBIN C & T CONTROL by Biotrol, USA, Inc. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1991
Date Received
November 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Biotrol, USA, Inc.

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  • 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)
  • K894544 — BIOTROL RUB-E.I.A. TEST G (August 30, 1989)
  • K891061 — BIOTROL CALCIUM MONOREACTIF (August 10, 1989)
  • K891286 — BIOTROL CHEMISTRY URINE CONTROL (April 10, 1989)

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