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510(k) K022661

A1CNOW FOR HOME USE by Metrika, Inc. — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2002
Date Received
August 9, 2002
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 Metrika, Inc.

  • K051321 — INVIEW (June 13, 2005)
  • K033847 — A1CNOW FOR HOME AND PROFESSIONAL USE (December 23, 2003)
  • K020234 — A1CNOW FOR RX HOME USE (February 15, 2002)
  • K020235 — A1CNOW FOR PROFESSIONAL USE (February 15, 2002)
  • K000885 — DRX HBA1C - FOR PRESCRIPTION HOME USE (September 26, 2000)
  • K000887 — DRX HBA1C (July 26, 2000)
  • K992997 — OSTEOMARK NTX POC (November 9, 1999)
  • K991532 — DRX QT. HCG (September 17, 1999)
  • K984530 — DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE (August 10, 1999)
  • K991917 — OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET (July 12, 1999)

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