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510(k) K950228

DSL ACTIVE IGFBP-3 IRMA (DSL 6600) by Diagnostic Systems Laboratories, Inc. — Product Code CFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1995
Date Received
January 11, 1995
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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Other clearances for product code CFL

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  • K971353 — DSL ACTIVE NON-EXTRACTION IGF-I ELISA (May 12, 1997)
  • K970701 — DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) (April 2, 1997)
  • K962758 — DSL 9100 IGF-II IRMA (August 30, 1996)
  • K961678 — HUMAN GROWTH HORMONE IMMUNOASSAY KIT (July 8, 1996)
  • K961172 — DSL ACTIVE NON-EXTRACTION IGF-I IRMA (April 23, 1996)
  • K960551 — DSL ACTIVE HUMAN GROWTH HORMONE ELISA (March 6, 1996)
  • K955376 — IMMULITE HGH (February 16, 1996)
  • 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)