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510(k) K972788

CROSSLAPS ELISA by Devices and Diagnostics Consulting Group — Product Code JMM

K972788 is an FDA 510(k) premarket notification submitted by Devices and Diagnostics Consulting Group for the device "CROSSLAPS ELISA". The FDA issued a decision of Substantially Equivalent on December 22, 1998. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1998
Date Received
July 28, 1997
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 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)
  • K992997 — OSTEOMARK NTX POC (November 9, 1999)
  • 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)
  • 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