Home / 510(k) Clearances / K850053

510(k) K850053

BACI 6 -ADRENOCORTICOTROOP HORMONE by Euro-Diagnostics BV — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1985
Date Received
January 8, 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 Euro-Diagnostics BV

  • K851332 — BLHI LUTEINIZING HORMONE (July 9, 1985)
  • K851148 — TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE (April 29, 1985)
  • K843930 — IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I (October 30, 1984)
  • K842478 — PROLACTIN IRMA (September 14, 1984)

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)