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510(k) K905473

UBI MAGIWEL CORTISOL QUANTITATIVE by United Biotech, Inc. — Product Code CGR

K905473 is an FDA 510(k) premarket notification submitted by United Biotech, Inc. for the device "UBI MAGIWEL CORTISOL QUANTITATIVE". The FDA issued a decision of Substantially Equivalent on January 31, 1991. The device falls under product code CGR (Radioimmunoassay, Cortisol), a Class II device regulated under 21 CFR 862.1205. United Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1991
Date Received
December 6, 1990
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 United Biotech, Inc.

  • K981573 — UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE (September 15, 1998)
  • K973154 — UBI MAGIWEL MARIJUANA METABOLITES (July 22, 1998)
  • K973692 — UBI MAGIWEL C-REACTIVE PROTEIN(CRP) QUANTITATIVE (February 9, 1998)
  • K973156 — UBI MAGIWEL COCAINE METABOLITES (October 28, 1997)
  • K973155 — UBI MAGIWEL OPIATE METABOLITES (October 28, 1997)
  • K973153 — UBI MAGIWEL AMPHETAMINE METABOLITES (October 28, 1997)
  • K962211 — UBI MAGIWEL THYROXINE (T4) QUANTITATIVE (July 8, 1996)
  • K961236 — UBI MAGIWEL TRIIODOTHYRONINE(T3) QUANTITATIVE (May 30, 1996)
  • K951993 — UBI MAGIWEL FERRITIN QUANTITATIVE (July 5, 1995)
  • K924689 — UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG (August 10, 1993)

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