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510(k) K831855

HATCH KIT by Radioassay Systems Laboratories, Inc. — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
June 9, 1983
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 Radioassay Systems Laboratories, Inc.

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  • K840886 — HYDROXYPROGESTERONE BY RIA 17A (April 18, 1984)
  • K802195 — DEHYDROEPIANDROSTERONE SULFATE KIT RIA (October 23, 1980)
  • K800126 — RSL (125 L) PROGESTERONE KIT (February 13, 1980)
  • K791999 — (125I) TESTOSTERONE KIT (October 30, 1979)
  • K791728 — RSL'S ASSAY PROCEDURE QUANTITATION (September 27, 1979)
  • K791835 — CORALENT COAT 125I CORTISOL RADIOIMM. (September 27, 1979)
  • K791740 — SERUM 11-DESOXYCORTISOL I AS TRACER (September 27, 1979)
  • K791651 — TOTAL ESTROGENS KIT BY RIA (September 27, 1979)

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  • K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (January 17, 2001)
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  • K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (December 24, 1996)
  • K960491 — MICRO HAEMATOCRIT CENTRIFUGE (October 18, 1996)
  • K960066 — IMMULITE ACTH (February 16, 1996)