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510(k) K812288

HUMAN C-PEPTIDE REAGENTS by Immunex Radiochemical Diagnostics — Product Code JKD

K812288 is an FDA 510(k) premarket notification submitted by Immunex Radiochemical Diagnostics for the device "HUMAN C-PEPTIDE REAGENTS". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code JKD (Radioimmunoassay, C-Peptides Of Proinsulin), a Class I device regulated under 21 CFR 862.1135.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
August 13, 1981
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 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)
  • K842267 — C-PEP-RIA-100 (September 6, 1984)
  • 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)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)

FDA data resources