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510(k) K100101

GSP NEONATALGALT KIT, MODEL 3303-001U by Perkinelmer, Inc. — Product Code KQP

K100101 is an FDA 510(k) premarket notification submitted by Perkinelmer, Inc. for the device "GSP NEONATALGALT KIT, MODEL 3303-001U". The FDA issued a decision of Substantially Equivalent on June 11, 2010. The device falls under product code KQP (Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase), a Class II device regulated under 21 CFR 862.1315. Perkinelmer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2010
Date Received
January 13, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Device Class
Class II
Regulation Number
862.1315
Review Panel
CH
Submission Type

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  • K193103 — NeoBase 2 Non-derivatized MSMS Kit (February 7, 2020)
  • DEN180056 — GSP Neonatal Creatine Kinase - MM kit (December 12, 2019)
  • K190335 — GSP Neonatal Total Galactose kit (November 6, 2019)
  • K190266 — NeoLSD MSMS Kit (May 3, 2019)
  • K161966 — PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector (September 8, 2016)
  • K161942 — PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector (September 1, 2016)
  • K142698 — PerkinElmer, XRpad 4343 F MED Flat Panel Detector (October 23, 2014)
  • K140551 — PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR (August 1, 2014)

Other clearances for product code KQP

  • K102643 — SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT (July 15, 2011)
  • K101392 — NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D (February 4, 2011)
  • K993536 — BIO-RAD CODA NEONATAL GALT ASSAY (November 4, 1999)
  • K990827 — MICROPLATE NEONATAL GALT ASSAY (April 9, 1999)
  • K970277 — URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) (December 11, 1997)
  • K894011 — TOTAL GALACTOSE (January 11, 1990)

FDA data resources