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510(k) K990843

SERUM CROSSLAPS ONE STEP ELISA by Osteometer Biotech A/S — Product Code JMM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1999
Date Received
March 15, 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 Osteometer Biotech A/S

  • K003609 — N-MID OSTEOCALCIN ONE STEP ELISA MODEL 30SC4000 (May 16, 2001)

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  • K992997 — OSTEOMARK NTX POC (November 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)