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510(k) K981208

TFR by Ramco Laboratories, Inc. — Product Code JNM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1998
Date Received
April 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunochemical, Transferrin
Device Class
Class II
Regulation Number
866.5880
Review Panel
IM
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)
  • K831470 — PTH MR (June 22, 1983)
  • K823016 — CANDIDA DETECTION SYSTEM (December 28, 1982)
  • K812056 — SPECTRO FEIRITIN (August 12, 1981)

Other clearances for product code JNM

  • K992188 — NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MO (December 6, 1999)
  • K970718 — QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (May 27, 1997)