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510(k) K895128

BIOTRACK ALT TEST CARTRIDGE by Biotrack, Inc. — Product Code CJJ

K895128 is an FDA 510(k) premarket notification submitted by Biotrack, Inc. for the device "BIOTRACK ALT TEST CARTRIDGE". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code CJJ (Diazo, Alt/Sgpt), a Class I device regulated under 21 CFR 862.1030. Biotrack, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
August 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo, Alt/Sgpt
Device Class
Class I
Regulation Number
862.1030
Review Panel
CH
Submission Type

Other clearances by Biotrack, Inc.

  • K934062 — BIOTRACK THERAPEUTIC DRUG-MONITORING QUAL CONTROLS (December 29, 1993)
  • K934061 — BIOTRACK VALPROIC ACID TEST CARTRIDGE (December 29, 1993)
  • K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL (August 5, 1992)
  • K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE (July 23, 1992)
  • K915756 — BIOTRACK CARBAMAZEPINE 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)
  • K895102 — BIOTRACK PDS MONITOR (October 10, 1989)
  • K895101 — BIOTRACK HEMOGLOBIN TEST CARTRIDGE (October 10, 1989)

Other clearances for product code CJJ

  • K943003 — CALCIUM QVET (December 9, 1994)

FDA data resources