TIPSEP DIGOXIN RIA— 510(k) K852291

Substantially Equivalent

Nuclear Diagnostics, Inc.

FDA 510(k) clearance K852291 for TIPSEP DIGOXIN RIA, Substantially Equivalent on 1985-06-25. Applicant: Nuclear Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Nuclear Diagnostics, Inc.
Product code: Code DNL
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1985-05-29
Decision date: 1985-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Troy, MI, US

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K802841 — DIGOXIN RADIOIMMUNOASSAY KIT1980-12-18
K781834 — TEST SET, 125 I-DIGOXIN1979-01-03

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K872177 — TIPSEP-CORTISOL RIA DIAGNOSTIC KIT1987-06-17
K862312 — ENZLIPASE, ENZYMATIC LIPASE KIT1986-09-26
K860472 — NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS1986-07-03

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