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510(k) K960171

ACTIVE CROSSLAPS ELISA by Diagnostic Systems Laboratories, Inc. — Product Code JMM

K960171 is an FDA 510(k) premarket notification submitted by Diagnostic Systems Laboratories, Inc. for the device "ACTIVE CROSSLAPS ELISA". The FDA issued a decision of Substantially Equivalent on March 28, 1996. The device falls under product code JMM (Column Chromatography & Color Development, Hydroxyproline), a Class I device regulated under 21 CFR 862.1400. Diagnostic Systems Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1996
Date Received
January 16, 1996
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 Diagnostic Systems Laboratories, Inc.

  • K061758 — ACTIVE RENIN IRMA (July 28, 2006)
  • K020945 — AXSYM INTACT PTH, MODEL 2G06 (May 31, 2002)
  • K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 (March 1, 2002)
  • K002128 — ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (December 5, 2000)
  • K001086 — FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900 (May 18, 2000)
  • K990138 — DSL ACTIVE AFP ELISA, MODEL DSL-10-8400 (June 21, 1999)
  • K981871 — C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 (November 9, 1998)
  • K973243 — ACTIVE PSA ELISA (DSL-10-9700) (August 3, 1998)
  • K973244 — ACTIVE PSA IRMA (DSL-9700) (August 3, 1998)
  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)

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)
  • 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)

FDA data resources