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510(k) K831470

PTH MR by Ramco Laboratories, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1983
Date Received
May 6, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

Other clearances by Ramco Laboratories, Inc.

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  • K872941 — SPECTRO C (September 4, 1987)
  • K864701 — VWF IMMUNOBLOT (March 30, 1987)
  • K861159 — SPECTRO VWF (May 1, 1986)
  • K823016 — CANDIDA DETECTION SYSTEM (December 28, 1982)
  • K812056 — SPECTRO FEIRITIN (August 12, 1981)

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