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510(k) K950481

NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT by Isolab, Inc. — Product Code JIA

K950481 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT". The FDA issued a decision of Substantially Equivalent on February 1, 1996. The device falls under product code JIA (Enzymatic Methods, Galactose), a Class I device regulated under 21 CFR 862.1310. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1996
Date Received
February 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic Methods, Galactose
Device Class
Class I
Regulation Number
862.1310
Review Panel
CH
Submission Type

Other clearances by Isolab, Inc.

  • K951014 — ISOLAB'S T4 TEST KIT (October 18, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)
  • K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (September 21, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K944185 — ISOSCAN (November 17, 1994)
  • K934013 — RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (April 26, 1994)
  • K923153 — HEMOCARD, HEMOGLOBIN C ASSAY (January 27, 1994)
  • K931234 — HEMOCARD CONTROL HB-AA, AE, FAA, FAE (May 11, 1993)

Other clearances for product code JIA

  • K190335 — GSP Neonatal Total Galactose kit (November 6, 2019)
  • K133652 — GSP NEONATAL TOTAL GALACTOSE KIT (April 28, 2014)
  • K121101 — SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (June 20, 2013)
  • K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND (August 7, 2008)
  • K990644 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY (June 21, 1999)
  • K990654 — QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT (June 21, 1999)
  • K991498 — ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL (June 16, 1999)
  • K951329 — IMMUCHEM GAL-MW EA (November 9, 1995)

FDA data resources