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510(k) K854876

ALDOSTERONE DIRECT RIA KIT by Biotecx Laboratories, Inc. — Product Code KQN

K854876 is an FDA 510(k) premarket notification submitted by Biotecx Laboratories, Inc. for the device "ALDOSTERONE DIRECT RIA KIT". The FDA issued a decision of Substantially Equivalent on March 17, 1986. The device falls under product code KQN (Radioassay, Angiotensin Converting Enzyme), a Class II device regulated under 21 CFR 862.1090. Biotecx Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1986
Date Received
December 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioassay, Angiotensin Converting Enzyme
Device Class
Class II
Regulation Number
862.1090
Review Panel
CH
Submission Type

Other clearances by Biotecx Laboratories, Inc.

  • K982298 — OPTICOAT T4 EIA KIT (February 3, 1999)
  • K981824 — OPTICOAT T3 EIA KIT (December 22, 1998)
  • K895407 — CORTISOL CLASP-BEAD EIA KIT (October 19, 1989)
  • K893620 — T3 CLASP-BEAD EIA KIT (August 11, 1989)
  • K892853 — T4 CLASP-BEAD EIA KIT (May 22, 1989)
  • K883765 — TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE (October 31, 1988)
  • K871211 — PROGESTERONE CLASP RADIOIMMUNOASSAY KIT (April 13, 1987)
  • K863188 — HPL RIA KIT (September 25, 1986)
  • K851540 — ESTRADIOL DIRECT RIA KIT (June 6, 1985)
  • K844767 — RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (February 1, 1985)

Other clearances for product code KQN

  • K041657 — THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT (August 30, 2004)
  • K942497 — ANGIOTENSIN CONVERTING ENZYME REA (November 15, 1994)
  • K913091 — BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY (August 26, 1991)
  • K854245 — SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV (January 22, 1986)
  • K833933 — ACE COLOR TEST (March 23, 1984)
  • K821011 — ACE ACTIVITY MICROVIAL TEST SET (May 3, 1982)
  • K791712 — ANGIOTENSIN CONVERTING ENZYME ASSAY SYS (September 19, 1979)

FDA data resources