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510(k) K850882

ACTH II BY RADIOIMMUNOASSAY by Immuno Nuclear Corp. — Product Code CKG

K850882 is an FDA 510(k) premarket notification submitted by Immuno Nuclear Corp. for the device "ACTH II BY RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on March 21, 1985. The device falls under product code CKG (Radioimmunoassay, Acth), a Class II device regulated under 21 CFR 862.1025. Immuno Nuclear Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1985
Date Received
March 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Acth
Device Class
Class II
Regulation Number
862.1025
Review Panel
CH
Submission Type

Other clearances by Immuno Nuclear Corp.

  • K863743 — BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT (December 15, 1986)
  • K863973 — ELM ALLERGEN DISC (December 1, 1986)
  • K863844 — IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC (October 29, 1986)
  • K863123 — IMMUNO BIOTECH MUGWART ALLERGEN DISC (October 1, 1986)
  • K863098 — MEADOW FESCUE ALLERGEN DISC (September 15, 1986)
  • K862266 — MAPLE ALLERGEN DISC (August 19, 1986)
  • K862938 — JUNE GRASS ALLERGEN DISC (August 15, 1986)
  • K862265 — COTTONWOOD ALLERGEN DISC (August 15, 1986)
  • K862176 — RUSSIAN THISTLE ALLERGEN DISC (August 15, 1986)
  • K862939 — ORCHARD GRASS ALLERGEN DISC (August 15, 1986)

Other clearances for product code CKG

  • K223867 — IDS ACTH II (August 18, 2023)
  • K111335 — ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321 (December 1, 2011)
  • K060585 — ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH (May 3, 2006)
  • K050748 — ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 (May 20, 2005)
  • K021032 — ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 (June 3, 2002)
  • K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (January 17, 2001)
  • K982608 — SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (August 19, 1998)
  • K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (December 24, 1996)
  • K960491 — MICRO HAEMATOCRIT CENTRIFUGE (October 18, 1996)
  • K960066 — IMMULITE ACTH (February 16, 1996)

FDA data resources