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510(k) K842267

C-PEP-RIA-100 by Institut National Des Radioelements — Product Code JKD

K842267 is an FDA 510(k) premarket notification submitted by Institut National Des Radioelements for the device "C-PEP-RIA-100". The FDA issued a decision of Substantially Equivalent on September 6, 1984. The device falls under product code JKD (Radioimmunoassay, C-Peptides Of Proinsulin), a Class I device regulated under 21 CFR 862.1135. Institut National Des Radioelements has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1984
Date Received
June 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, C-Peptides Of Proinsulin
Device Class
Class I
Regulation Number
862.1135
Review Panel
CH
Submission Type

Other clearances by Institut National Des Radioelements

  • K791128 — PTH RIA 200 (September 27, 1979)

Other clearances for product code JKD

  • K951848 — AIA-PACK CPR ASSAY (February 13, 1996)
  • K943767 — IMMULITE C-PEPTIDE (March 23, 1995)
  • K896420 — DSL C-PEPTIDE RIA (DSL #7000) (May 24, 1990)
  • K854066 — DOUBLE ANTIBODY C-PEPTIDE RIA KIT (November 12, 1985)
  • K833396 — C-PEPTIDE RADIOIMMUNOASSAY TEST KIT (April 13, 1984)
  • K820666 — HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. (July 13, 1982)
  • K812689 — RIA QUANT C-PEPTIDE KIT (October 6, 1981)
  • K812288 — HUMAN C-PEPTIDE REAGENTS (August 31, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)

FDA data resources