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510(k) K993536

BIO-RAD CODA NEONATAL GALT ASSAY by Bio-Rad — Product Code KQP

K993536 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "BIO-RAD CODA NEONATAL GALT ASSAY". The FDA issued a decision of Substantially Equivalent on November 4, 1999. 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. Bio-Rad has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1999
Date Received
October 19, 1999
Clearance Type
Special
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

Other clearances by Bio-Rad

  • K171061 — MRSASelect II (December 28, 2017)
  • K122187 — VRESELECT CULTURE MEDIUM (November 6, 2012)
  • K103684 — VRESELECT CULTURE MEDIUM (October 21, 2011)
  • K093678 — PLATELIA ASPERGILLUS EIA MODEL 62793 (January 13, 2011)
  • K100589 — MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS (October 29, 2010)
  • K081362 — PLATELIA LYME IGM (June 26, 2008)
  • K081212 — MRSASELECT - EXTENDED INCUBATION (June 13, 2008)
  • K080012 — PLATELIA LYME IGG ASSAY (May 8, 2008)
  • K070361 — MRSASELECT (September 13, 2007)
  • K060641 — PLATELIA ASPERGILLUS EIA, MODEL 62793 (June 2, 2006)

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)
  • K100101 — GSP NEONATALGALT KIT, MODEL 3303-001U (June 11, 2010)
  • 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