ACID PHOSPHATASE ASSAY KIT— 510(k) K843380

Name: FDA 510(k) clearance K843380
Creator: U.S. Food and Drug Administration
Published: 1984-09-20

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K843380 for ACID PHOSPHATASE ASSAY KIT, Substantially Equivalent on 1984-09-20. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CKE
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1984-08-28
Decision date: 1984-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CKE

view all

K914167 — CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE1992-03-17
K915705 — ACID PHOSPHATASE REAGENT SET1992-02-27
K873726 — ACID PHOSPHATASE TEST1988-01-27
K864230 — DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM1986-11-28
K860476 — ACID PHOSPHATASE REAGENT SET1986-03-05

More clearances from Diagnostic Chemicals, Ltd. (Usa)

view all

K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-252002-08-23
K974874 — BILIRUBIN-SL (TOTAL) ASSAY1998-02-12
K932556 — AMMONIA ASSAY CAT. NO. 200-021994-08-02
K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)1993-12-10
K932555 — DC-LINEATE CAT. NO. SE-0911993-08-19

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