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510(k) K820768

COLORIMETRIC LDH REAGENT SET by Biorent Diagnostic, Inc. — Product Code CFH

K820768 is an FDA 510(k) premarket notification submitted by Biorent Diagnostic, Inc. for the device "COLORIMETRIC LDH REAGENT SET". The FDA issued a decision of Substantially Equivalent on April 14, 1982. The device falls under product code CFH (Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase), a Class II device regulated under 21 CFR 862.1440. Biorent Diagnostic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
March 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
Device Class
Class II
Regulation Number
862.1440
Review Panel
CH
Submission Type

Other clearances by Biorent Diagnostic, Inc.

  • K832747 — ALBUMIN REAGENT SET (October 14, 1983)
  • K823060 — HEMOGLOBIN REAGENT (November 22, 1982)
  • K823211 — CK-UV REAGENT (November 22, 1982)
  • K822493 — OPTIMIZED UV-GOT REAGENT SET (September 21, 1982)
  • K822494 — OPTIMIZED UV-GPT REAGENT SET (September 21, 1982)
  • K822492 — OPTIMIZED UV-LDH REAGENT SET (September 17, 1982)
  • K820632 — COLORIMETRIC URIC ACID REAGENT SET (March 25, 1982)
  • K813555 — GLUCOSE ENZYME-COLOR REAGENT SET (January 18, 1982)
  • K813244 — UV URIC ACID DETERMINATION (December 8, 1981)
  • K811760 — CHOLESTEROL DETERMINATION (July 10, 1981)

Other clearances for product code CFH

  • K050790 — SPOTCHEM II LDH TEST (June 6, 2005)
  • K020484 — CARESIDE LDH (July 3, 2002)
  • K895138 — CLINISTAT LDH REAGENT TEST (October 19, 1989)
  • K894578 — IQ LDH (October 17, 1989)
  • K880630 — LACTATE DEHYDROGENASE (LDH-L) (March 16, 1988)
  • K860349 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (February 28, 1986)
  • K852391 — EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE (October 1, 1985)
  • K842452 — WAKO LDH CII TEST (August 15, 1984)
  • K812836 — LDH REAGENT SET (October 9, 1981)
  • K782176 — HYCEL LDH-INT TEST (January 26, 1979)

FDA data resources