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510(k) K882823

FIAGEN HGH FLUOROIMMUNOASSAY KIT by Cyberfluor, Inc. — Product Code CFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1988
Date Received
July 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Human Growth Hormone
Device Class
Class I
Regulation Number
862.1370
Review Panel
CH
Submission Type

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  • K960551 — DSL ACTIVE HUMAN GROWTH HORMONE ELISA (March 6, 1996)
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  • K955390 — INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY (December 29, 1995)
  • K952505 — INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (July 3, 1995)