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510(k) K946247

IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 by Nichols Institute — Product Code CFL

K946247 is an FDA 510(k) premarket notification submitted by Nichols Institute for the device "IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3". The FDA issued a decision of Substantially Equivalent on June 23, 1995. The device falls under product code CFL (Radioimmunoassay, Human Growth Hormone), a Class I device regulated under 21 CFR 862.1370. Nichols Institute has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1995
Date Received
December 22, 1994
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 Nichols Institute

  • K952559 — ERYTHROPOIETIN IMMUNOASSAY KIT (May 29, 1996)
  • K952505 — INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) (July 3, 1995)
  • K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (May 15, 1995)
  • K932650 — ERYTHROPOIETIN IMMUNOASSAY KIT (March 11, 1994)
  • K931600 — CHEMILUMINESCENCE FREE T3 IMMUNOASSAY (September 8, 1993)
  • K931777 — APO A-1 CHEMILUMINESCENCE ASSAY (August 16, 1993)
  • K931601 — CHEMILUMINESCENCE DHEA-S IMMUNOASSAY (July 27, 1993)
  • K926396 — ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT (July 27, 1993)
  • K931311 — THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT (May 14, 1993)
  • K930777 — THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT (April 8, 1993)

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