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510(k) K935013

DSL ESTRONE (DSL 8700) by Diagnostic Systems Laboratories, Inc. — Product Code CGF

K935013 is an FDA 510(k) premarket notification submitted by Diagnostic Systems Laboratories, Inc. for the device "DSL ESTRONE (DSL 8700)". The FDA issued a decision of Substantially Equivalent on June 16, 1994. The device falls under product code CGF (Radioimmunoassay, Estrone), a Class I device regulated under 21 CFR 862.1280. Diagnostic Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1994
Date Received
October 20, 1993
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

Other clearances by Diagnostic Systems Laboratories, Inc.

  • K061758 — ACTIVE RENIN IRMA (July 28, 2006)
  • K020945 — AXSYM INTACT PTH, MODEL 2G06 (May 31, 2002)
  • K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 (March 1, 2002)
  • K002128 — ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (December 5, 2000)
  • K001086 — FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (May 18, 2000)
  • K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (June 21, 1999)
  • K981871 — C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (November 9, 1998)
  • K973243 — ACTIVE PSA ELISA (DSL-10-9700) (August 3, 1998)
  • K973244 — ACTIVE PSA IRMA (DSL-9700) (August 3, 1998)
  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)

Other clearances for product code CGF

  • K970915 — DSL ESTRONE-SULFATE RIA (May 16, 1997)
  • K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (January 9, 1987)
  • K833406 — IMMOPHASE D-TE 3 RADIOIMMUNOASSAY (January 24, 1984)

FDA data resources