PANTRAK E.K.— 510(k) K810669

Substantially Equivalent

Calbiochem-Behring Corp.

FDA 510(k) clearance K810669 for PANTRAK E.K., Substantially Equivalent on 1981-03-31. Applicant: Calbiochem-Behring Corp.. Device class: 2.

Clearance details

Applicant: Calbiochem-Behring Corp.
Product code: Code CIW
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1981-03-12
Decision date: 1981-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIW

K931559 — DMA AMYLASE PROCEDURE1993-10-28
K924339 — OLYMPUS AMYLASE REAGENT1992-10-19
K884382 — AMYLASE TEST (AMYL) ITEM NUMBER: 656531989-01-11
K850639 — ENZYMATIC ALPHA-AMYLASE REAGENT KIT1985-03-05
K812027 — KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)1981-08-03

More clearances from Calbiochem-Behring Corp.

K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE1983-07-28
K831036 — ENA TEST KIT SM & RNP AUTO ANTIBODY1983-04-27
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.