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510(k) K912858

LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY by London Diagnostics, Inc. — Product Code CFL

K912858 is an FDA 510(k) premarket notification submitted by London Diagnostics, Inc. for the device "LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY". The FDA issued a decision of Substantially Equivalent on July 30, 1991. The device falls under product code CFL (Radioimmunoassay, Human Growth Hormone), a Class I device regulated under 21 CFR 862.1370. London Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1991
Date Received
June 28, 1991
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 London Diagnostics, Inc.

  • K914835 — LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY (December 17, 1991)
  • K911985 — LUMATAG T4 CHEMILUMINESCENCE ASSAY (August 2, 1991)
  • K905814 — LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY (February 4, 1991)
  • K904458 — LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION (October 12, 1990)
  • K903130 — LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY (September 25, 1990)
  • K902443 — LUMATAG(TM) LH DIAGNOSTIC KIT (August 2, 1990)
  • K903195 — LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY (August 2, 1990)
  • K901484 — LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC (May 1, 1990)
  • K901075 — LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. (April 2, 1990)
  • K881443 — LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY (May 27, 1988)

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