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510(k) K921855

BIOTROL BICARBONATE STANDARDS by Biotrol, USA, Inc. — Product Code JIS

K921855 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL BICARBONATE STANDARDS". The FDA issued a decision of Substantially Equivalent on August 3, 1992. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1992
Date Received
April 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Biotrol, USA, Inc.

  • K934014 — VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT (December 6, 1995)
  • K931141 — BIOTROL AMYLASE CNPG3 (May 26, 1993)
  • 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)
  • K891286 — BIOTROL CHEMISTRY URINE CONTROL (April 10, 1989)

Other clearances for product code JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)

FDA data resources