VMA ASSAY KIT— 510(k) K843379

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K843379 for VMA ASSAY KIT, Substantially Equivalent on 1984-09-28. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code CDF
Device class: Class 1
Regulation: 21 CFR 862.1795
Advisory panel: Clinical Chemistry
Date received: 1984-08-28
Decision date: 1984-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, US

Download summary PDF View on FDA.gov ↗

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More clearances from Diagnostic Chemicals, Ltd. (Usa)

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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.