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510(k) K992997

OSTEOMARK NTX POC by Metrika, Inc. — Product Code JMM

K992997 is an FDA 510(k) premarket notification submitted by Metrika, Inc. for the device "OSTEOMARK NTX POC". The FDA issued a decision of Substantially Equivalent on November 9, 1999. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Metrika, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1999
Date Received
September 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Column Chromatography & Color Development, Hydroxyproline
Device Class
Class I
Regulation Number
862.1400
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)
  • 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)

Other clearances for product code JMM

  • K011052 — OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (July 30, 2001)
  • K993706 — ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (July 24, 2000)
  • K990843 — SERUM CROSSLAPS ONE STEP ELISA (July 9, 1999)
  • K983457 — OSTEOMARK NTX SERUM EIA (February 2, 1999)
  • K983674 — VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROL (January 29, 1999)
  • K972788 — CROSSLAPS ELISA (December 22, 1998)
  • K981364 — PYRILINKS-D ASSAY KIT (August 13, 1998)
  • K980833 — IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (May 1, 1998)
  • K980518 — OSTEOMARK (March 6, 1998)
  • K974260 — PYRILINKS-D ASSAY KIT (January 26, 1998)

FDA data resources