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510(k) K921868

ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT by Endocrine Sciences Products — Product Code CFL

K921868 is an FDA 510(k) premarket notification submitted by Endocrine Sciences Products for the device "ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT". The FDA issued a decision of Substantially Equivalent on January 3, 1994. The device falls under product code CFL (Radioimmunoassay, Human Growth Hormone), a Class I device regulated under 21 CFR 862.1370. Endocrine Sciences Products has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1994
Date Received
April 20, 1992
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 Endocrine Sciences Products

  • K833805 — GLYCOGLOBIN KIT (January 3, 1984)

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)
  • 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)

FDA data resources