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510(k) K002128

ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 by Diagnostic Systems Laboratories, Inc. — Product Code NDR

K002128 is an FDA 510(k) premarket notification submitted by Diagnostic Systems Laboratories, Inc. for the device "ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100". The FDA issued a decision of Substantially Equivalent on December 5, 2000. The device falls under product code NDR (Enzyme Immunoassay, Inhibin-A), a Class I device regulated under 21 CFR 862.1260. Diagnostic Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2000
Date Received
July 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Inhibin-A
Device Class
Class I
Regulation Number
862.1260
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)
  • 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)
  • K973514 — ACTIVE INTACT PTH (October 31, 1997)

FDA data resources