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510(k) K943767

IMMULITE C-PEPTIDE by Diagnostic Products Corp. — Product Code JKD

K943767 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE C-PEPTIDE". The FDA issued a decision of Substantially Equivalent on March 23, 1995. The device falls under product code JKD (Radioimmunoassay, C-Peptides Of Proinsulin), a Class I device regulated under 21 CFR 862.1135. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1995
Date Received
August 2, 1994
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 Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code JKD

  • K951848 — AIA-PACK CPR ASSAY (February 13, 1996)
  • 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)
  • K812288 — HUMAN C-PEPTIDE REAGENTS (August 31, 1981)
  • K810718 — C-PEPTICE REAGENTS (March 31, 1981)

FDA data resources