Home / 510(k) Clearances / K991917

510(k) K991917

OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET by Metrika, Inc. — Product Code JJW

K991917 is an FDA 510(k) premarket notification submitted by Metrika, Inc. for the device "OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET". The FDA issued a decision of Substantially Equivalent on July 12, 1999. The device falls under product code JJW (Urinalysis Controls (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Metrika, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1999
Date Received
June 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinalysis Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Metrika, Inc.

  • K051321 — INVIEW (June 13, 2005)
  • K033847 — A1CNOW FOR HOME AND PROFESSIONAL USE (December 23, 2003)
  • K022661 — A1CNOW FOR HOME USE (December 13, 2002)
  • K020235 — A1CNOW FOR PROFESSIONAL USE (February 15, 2002)
  • K020234 — A1CNOW FOR RX HOME 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)

Other clearances for product code JJW

  • K170091 — UA-Cellular Complete (February 9, 2017)
  • K142262 — AUTION CHECK PLUS (April 10, 2015)
  • K131444 — UA-CELLULAR COMPLETE (January 29, 2014)
  • K110846 — RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 (September 30, 2011)
  • K103387 — MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY (February 2, 2011)
  • K081908 — CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 (January 16, 2009)
  • K072640 — IRISPEC,CA/CB/CC (December 21, 2007)
  • K070848 — LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,43 (April 25, 2007)
  • K052242 — ADVIA CHEMISTRY MICROALBUMIN CONTROLS (October 3, 2005)
  • K043266 — RANDOX URINE CONTROLS (February 15, 2005)

FDA data resources