C-PEPTICE REAGENTS— 510(k) K810718

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K810718 for C-PEPTICE REAGENTS, Substantially Equivalent on 1981-03-31. Applicant: Calbiochem-Behring Corp.. Device class: 1.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code JKD
Device class: Class 1
Regulation: 21 CFR 862.1135
Advisory panel: Clinical Chemistry
Date received: 1981-03-17
Decision date: 1981-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JKD

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K943767 — IMMULITE C-PEPTIDE1995-03-23
K896420 — DSL C-PEPTIDE RIA (DSL #7000)1990-05-24
K854066 — DOUBLE ANTIBODY C-PEPTIDE RIA KIT1985-11-12
K842267 — C-PEP-RIA-1001984-09-06

More clearances from Calbiochem-Behring Corp.

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K830214 — AFT SYSTEM III1983-03-09
K820812 — CREATINE KINASE-MB KIT1982-04-12
K813493 — ENZYGNOST TM RUBELLA IGM1982-03-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.