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510(k) K821867

ULTRACHEM GLUC-DH by Harleco Diagnostics — Product Code LFR

K821867 is an FDA 510(k) premarket notification submitted by Harleco Diagnostics for the device "ULTRACHEM GLUC-DH". The FDA issued a decision of Substantially Equivalent on July 6, 1982. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Harleco Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1982
Date Received
June 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Dehydrogenase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Harleco Diagnostics

  • K823147 — URIC ACID STANDARD, 8MG/DL #65078 (November 22, 1982)
  • K822852 — TRIGLYCERIDE CALIBRATOR (October 27, 1982)
  • K822323 — ULTRACHEM BUN-UV, 65080 & 65081 (September 2, 1982)
  • K821879 — ULTRACHEM T.P. (July 14, 1982)
  • K821878 — ULTRAZYME PLUS LDH (July 14, 1982)
  • K821871 — ULTRAZYME PLUS 2GT (July 14, 1982)
  • K821877 — ULTRAZYME PLUS HBD (July 14, 1982)
  • K821883 — ULTRAZYME PLUS CK-I (July 14, 1982)
  • K821882 — ULTRAZYME PLUS GPT (July 14, 1982)
  • K821872 — ULTRACHEM URIC ACID AIDH (July 14, 1982)

Other clearances for product code LFR

  • K152328 — FreeStyle InsuLinx Blood Glucose Monotioring System (September 17, 2015)
  • K142089 — ACCU-CHEK AVIVA EXPERT SYSTEM (December 17, 2014)
  • K133537 — EGV1.1 SELF MONITORING BLOOD GLUCOSE SYSTEM AND EGV1.1 PRO MONITORING BLOOD GLUC (April 28, 2014)
  • K131727 — CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM (February 28, 2014)
  • K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (October 11, 2013)
  • K122688 — NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR (April 4, 2013)
  • K121433 — GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT USE) (February 14, 2013)
  • K122435 — NOVA ONE BLOOD GLUCOSE MONITOR (December 20, 2012)
  • K113314 — PRECICHEK NS-101 POCT PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM (November 9, 2012)
  • K121224 — GENESIS HEALTH TECHNOLOGIES BLOOD GLUCOSE MONITORING SYSTEM (September 19, 2012)

FDA data resources