DNA STAT TEST KIT— 510(k) K843904

Substantially Equivalent

Whittaker Bioproducts, Inc.

FDA 510(k) clearance K843904 for DNA STAT TEST KIT, Substantially Equivalent on 1984-11-01. Applicant: Whittaker Bioproducts, Inc.. Device class: 2.

Clearance details

Applicant: Whittaker Bioproducts, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1984-10-03
Decision date: 1984-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walkersville, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Whittaker Bioproducts, Inc.

K911356 — LEGIONELLA STAT IGG/IGM TEST KIT1992-07-30
K913212 — 3M IGE SINGLE POINT FAST TEST1991-11-22
K904652 — LYME STAT M TEST KIT1991-10-21
K904893 — FIAX LYME M TEST KIT1991-10-16
K911473 — EBNA STAT TEST KIT1991-09-25

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