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510(k) K970701

DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) by Diagnostic Systems Laboratories, Inc. — Product Code CFL

K970701 is an FDA 510(k) premarket notification submitted by Diagnostic Systems Laboratories, Inc. for the device "DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)". The FDA issued a decision of Substantially Equivalent on April 2, 1997. The device falls under product code CFL (Radioimmunoassay, Human Growth Hormone), a Class I device regulated under 21 CFR 862.1370. Diagnostic Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1997
Date Received
February 26, 1997
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

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)
  • 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 CFL

  • K972761 — SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY (September 25, 1997)
  • K971353 — DSL ACTIVE NON-EXTRACTION IGF-I ELISA (May 12, 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)
  • K946247 — IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 (June 23, 1995)

FDA data resources