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510(k) K862336

PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT by Pantex, Div. Bio-Analysis, Inc. — Product Code CGR

K862336 is an FDA 510(k) premarket notification submitted by Pantex, Div. Bio-Analysis, Inc. for the device "PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on September 25, 1986. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. Pantex, Div. Bio-Analysis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1986
Date Received
June 20, 1986
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 Pantex, Div. Bio-Analysis, Inc.

  • K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (May 8, 2012)
  • K942658 — NEOSCREEN ELISA TSH (February 24, 1995)
  • K914107 — PROLACTIN IRMA IMMUNOMAG (September 30, 1991)
  • K912804 — FSH IRMA IMMUNOMAG (August 12, 1991)
  • K911839 — NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT (June 18, 1991)
  • K911050 — LH IRMA IMMUNOMAG (April 12, 1991)
  • K910717 — PANTEX IRMA LH 1251 KIT (March 19, 1991)
  • K894049 — IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT (September 8, 1989)
  • K862483 — PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT (January 14, 1987)
  • K862447 — PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT (October 7, 1986)

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