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510(k) K895102

BIOTRACK PDS MONITOR by Biotrack, Inc. — Product Code JJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1989
Date Received
August 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class
Class I
Regulation Number
862.2300
Review Panel
CH
Submission Type

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  • K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL (August 5, 1992)
  • K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE (July 23, 1992)
  • K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE (July 23, 1992)
  • K903924 — BIOTRACK THEOPHYLLINE QUALITY CONTROLS (September 17, 1990)
  • K900373 — BIOTRACK THEOPHYLLINE TEST CARTRIDGE (May 30, 1990)
  • K900372 — BIOTRACK IMMUNOCHEMISTRY MONITOR (February 23, 1990)
  • K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE (October 10, 1989)
  • K895128 — BIOTRACK ALT TEST CARTRIDGE (October 6, 1989)

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