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510(k) K930484

DELFIA(R) HGH KIT by Wallac OY — Product Code CFL

K930484 is an FDA 510(k) premarket notification submitted by Wallac OY for the device "DELFIA(R) HGH KIT". The FDA issued a decision of Substantially Equivalent on May 11, 1993. The device falls under product code CFL (Radioimmunoassay, Human Growth Hormone), a Class I device regulated under 21 CFR 862.1370. Wallac OY has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1993
Date Received
January 29, 1993
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 Wallac OY

  • DEN140010 — PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (December 15, 2014)
  • K131284 — GSP NEONATAL BIOTINIDASE KIT (November 14, 2013)
  • K100682 — GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U (July 23, 2010)
  • K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (April 16, 2009)
  • K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND (August 7, 2008)
  • K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (April 14, 2008)
  • K050709 — RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, (March 8, 2006)
  • K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (July 11, 2005)
  • K042425 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)

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