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510(k) K812689

RIA QUANT C-PEPTIDE KIT by Mallinckrodt Critical Care — Product Code JKD

K812689 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "RIA QUANT C-PEPTIDE KIT". The FDA issued a decision of Substantially Equivalent on October 6, 1981. The device falls under product code JKD (Radioimmunoassay, C-Peptides Of Proinsulin), a Class I device regulated under 21 CFR 862.1135. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1981
Date Received
September 22, 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 by Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

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)
  • K812288 — HUMAN C-PEPTIDE REAGENTS (August 31, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)

FDA data resources