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510(k) K972904

DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL by Casco Standards — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1998
Date Received
August 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K960244 — DOCUMENT TDM ULTRA ASSAYED CONTROL (March 22, 1996)
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  • K945718 — DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET (January 17, 1995)
  • K945315 — DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL (December 9, 1994)
  • K944361 — DOCUMENT R AMMONIA/ETHANOL CONTROL (November 30, 1994)

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