Home / 510(k) Clearances / K904814

510(k) K904814

GLYC-AFFIN GP by Isolab, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1990
Date Received
October 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

Other clearances by Isolab, Inc.

  • K951014 — ISOLAB'S T4 TEST KIT (October 18, 1996)
  • K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (February 1, 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)

Other clearances for product code LCP

  • K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer (November 22, 2024)
  • K231465 — Q-Pad Test System (December 6, 2023)
  • K214117 — Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer (September 27, 2023)
  • K192987 — Aina HbA1c Monitoring System 2 (March 26, 2020)
  • K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (October 29, 2019)
  • K183230 — OneDraw A1C Test System (August 15, 2019)
  • K181915 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (April 12, 2019)
  • K180509 — Quo-Test A1c System (February 16, 2019)
  • K173127 — skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c (September 25, 2018)
  • K170623 — ACE Hemoglobin A1c (HbA1c) Reagent (February 27, 2018)