Home / 510(k) Clearances / K895407

510(k) K895407

CORTISOL CLASP-BEAD EIA KIT by Biotecx Laboratories, Inc. — Product Code CGR

K895407 is an FDA 510(k) premarket notification submitted by Biotecx Laboratories, Inc. for the device "CORTISOL CLASP-BEAD EIA KIT". The FDA issued a decision of Substantially Equivalent on October 19, 1989. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Biotecx Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1989
Date Received
September 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cortisol
Device Class
Class II
Regulation Number
862.1205
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)
  • 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)
  • K854876 — ALDOSTERONE DIRECT RIA KIT (March 17, 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 CGR

  • K242190 — Access Cortisol; DxC 500i Clinical Analyzer (March 5, 2025)
  • K223038 — Access Cortisol (February 8, 2023)
  • K202136 — IDS Cortisol (April 13, 2021)
  • K203270 — IMMULITE/IMMULITE® 1000 Cortisol (January 15, 2021)
  • K202826 — IMMULITE® 2000 Cortisol (January 15, 2021)
  • K062626 — CORTISOL ELISA (December 20, 2006)
  • K060480 — VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METAB (July 3, 2006)
  • K052359 — IBL CORTISOL LIA TEST KIT (October 3, 2005)
  • K050202 — CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (February 9, 2005)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)

FDA data resources