ACID PHOSPHATASE TEST— 510(k) K873726

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K873726 for ACID PHOSPHATASE TEST, Substantially Equivalent on 1988-01-27. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code CKE
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1987-09-15
Decision date: 1988-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CKE

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K860476 — ACID PHOSPHATASE REAGENT SET1986-03-05
K843380 — ACID PHOSPHATASE ASSAY KIT1984-09-20

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K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT1992-11-02

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