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510(k) K993132

GENZYME DIRECT AMYLASE VERIFIER by Genzyme Corp. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1999
Date Received
September 20, 1999
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Genzyme Corp.

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  • K040868 — SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH (June 4, 2004)
  • K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST (April 2, 2004)
  • K023544 — GENZYME CONTRAST II HCG URINE/SERUM TEST (January 16, 2003)
  • K021316 — ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTR (July 25, 2002)
  • K021019 — COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE (June 18, 2002)
  • K012532 — SEPRAGEL SINUS (October 30, 2001)
  • K011843 — GENZYME DIRECT-AMYLASE TEST REAGENT (August 10, 2001)

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  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)
  • K163521 — Lumipulse G LH Calibrators (January 12, 2017)
  • K163544 — Lumipulse G Prolactin (January 12, 2017)
  • K163078 — DC-UIBC-CAL (December 8, 2016)
  • K163053 — Lumipulse G E2-III Calibrators (December 1, 2016)
  • K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Cal (November 17, 2016)