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510(k) K970915

DSL ESTRONE-SULFATE RIA by Diagnostic Systems Laboratories, Inc. — Product Code CGF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1997
Date Received
March 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estrone
Device Class
Class I
Regulation Number
862.1280
Review Panel
CH
Submission Type

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  • K973244 — ACTIVE PSA IRMA (DSL-9700) (August 3, 1998)
  • K973243 — ACTIVE PSA ELISA (DSL-10-9700) (August 3, 1998)
  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)

Other clearances for product code CGF

  • K935013 — DSL ESTRONE (DSL 8700) (June 16, 1994)
  • K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (January 9, 1987)
  • K833406 — IMMOPHASE D-TE 3 RADIOIMMUNOASSAY (January 24, 1984)